Trial Outcomes & Findings for A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) (NCT NCT04924114)
NCT ID: NCT04924114
Last Updated: 2025-08-29
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Up to approximately 85 days
Results posted on
2025-08-29
Participant Flow
Upon concluding the Initial Blinded Treatment (IBT) phase, participants could either complete the study or enter one of the next 2 phases. Participants who achieved clinical response could enter the continued blinded treatment (CBT) phase and continue receiving the same treatment as the IBT phase. Participants who did not achieve clinical response could enter an open label (OL) phase and receive MK-6194 at the same dose/regimen of their IBT cohort for active MK-6194 treatment.
Participant milestones
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
11
|
18
|
10
|
11
|
|
Overall Study
Continued in CBT Phase
|
2
|
1
|
2
|
3
|
3
|
|
Overall Study
Treated in CBT Phase
|
2
|
1
|
2
|
3
|
3
|
|
Overall Study
Continued in OL Phase
|
2
|
3
|
4
|
0
|
2
|
|
Overall Study
Treated in OL Phase
|
3
|
4
|
4
|
0
|
0
|
|
Overall Study
COMPLETED
|
7
|
9
|
16
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
0
|
2
|
Baseline Characteristics
A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)
Baseline characteristics by cohort
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
n=11 Participants
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.4 Years
STANDARD_DEVIATION 11.59 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 14.64 • n=7 Participants
|
47.7 Years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
43.3 Years
STANDARD_DEVIATION 10.11 • n=4 Participants
|
35.6 Years
STANDARD_DEVIATION 11.85 • n=21 Participants
|
43.2 Years
STANDARD_DEVIATION 12.31 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 85 daysPopulation: All participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
n=11 Participants
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
7 Participants
|
10 Participants
|
18 Participants
|
10 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 72 daysPopulation: All participants who received at least one dose of study drug
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to thestudy intervention
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
n=11 Participants
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Number of Participants Who Interrupted or Discontinued Study Treatment Due to an AE
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85.Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacokinetic (PK) profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Blood samples were collected at pre-specified time points to determine each participant's maximum concentration (Cmax). A participant's Cmax was defined as the maximum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the maximum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmax were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=9 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-6194
|
9.55 ng/mL
Geometric Coefficient of Variation 67.80
|
30.02 ng/mL
Geometric Coefficient of Variation 95.85
|
51.80 ng/mL
Geometric Coefficient of Variation 71.97
|
52.78 ng/mL
Geometric Coefficient of Variation 178.96
|
—
|
SECONDARY outcome
Timeframe: Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect he pharmacokinetic (PK) profile. Per protocol, samples from participants receiving placebo were not analyzed for PK values.
Blood samples were collected at pre-specified time points to determine maximum concentration (Cmax) of MK-6194 in each participant's serum and corresponding time of maximum concentration (Tmax). A participant's Tmax was defined as the time post-dose that the maximum concentration of MK-6194 was observed in serum. The median and range of Tmax were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=9 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of MK-6194
|
12.00 hours
Interval 11.1 to 24.0
|
12.00 hours
Interval 11.5 to 24.5
|
12.05 hours
Interval 11.1 to 25.0
|
12.10 hours
Interval 11.2 to 12.2
|
—
|
SECONDARY outcome
Timeframe: Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples participants receiving placebo were not analyzed for PK values.
Blood samples were collected at pre-specified time points to determine the minimum concentration (Cmin) of MK-6194 present in each participant's serum. A participant's Cmin was defined as the minimum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the minimum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmin were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=9 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Minimum Concentration (Cmin) of MK-6194
|
0.08 ng/mL
Geometric Coefficient of Variation 0.00
|
0.08 ng/mL
Geometric Coefficient of Variation 0.00
|
0.09 ng/mL
Geometric Coefficient of Variation 97.70
|
0.08 ng/mL
Geometric Coefficient of Variation 0.00
|
—
|
SECONDARY outcome
Timeframe: Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants receiving placebo were not analyzed for PK values.
Blood samples were collected at pre-specified time points to determine the apparent half-life (t1/2) of MK-6194. Noncompartmental analysis was used to calculate t1/2 for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of t1/2 were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=6 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=5 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=10 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=9 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Apparent Half-life (t1/2) of MK-6194
|
193.28 hours
Geometric Coefficient of Variation 66.51
|
52.84 hours
Geometric Coefficient of Variation 23.89
|
42.06 hours
Geometric Coefficient of Variation 80.41
|
96.09 hours
Geometric Coefficient of Variation 16.51
|
—
|
SECONDARY outcome
Timeframe: Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants receiving placebo were not analyzed for PK values.
Blood samples were collected at pre-specified time points to determine the apparent clearance (CL/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate CL/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of CL/F were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=9 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of MK-6194
|
0.00 L/hours
Geometric Coefficient of Variation 66.28
|
0.01 L/hours
Geometric Coefficient of Variation 82.72
|
0.01 L/hours
Geometric Coefficient of Variation 95.07
|
0.01 L/hours
Geometric Coefficient of Variation 78.70
|
—
|
SECONDARY outcome
Timeframe: Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Blood samples were collected at pre-specified time points to determine the apparent volume of distribution (Vd/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate Vd/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of Vd/F were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=6 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=5 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=10 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=9 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of MK-6194
|
1.61 Liters
Geometric Coefficient of Variation 121.12
|
0.82 Liters
Geometric Coefficient of Variation 96.99
|
0.55 Liters
Geometric Coefficient of Variation 226.96
|
0.81 Liters
Geometric Coefficient of Variation 93.17
|
—
|
SECONDARY outcome
Timeframe: Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Blood samples were collected at pre-specified timepoints to determine the AUC0-t of MK-6194. AUC0-t is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to the last quantifiable concentration. Noncompartmental analysis was used to calculate AUC0-t for each participant. Geometric mean and geometric coefficient of variation of AUC0-t were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=9 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t)
|
955.51 ng*hour/mL
Geometric Coefficient of Variation 39.92
|
2080.46 ng*hour/mL
Geometric Coefficient of Variation 55.64
|
3546.54 ng*hour/mL
Geometric Coefficient of Variation 67.17
|
3203.50 ng*hour/mL
Geometric Coefficient of Variation 117.92
|
—
|
SECONDARY outcome
Timeframe: Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the PK profile. Per protocol, samples from participants who received placebo were not analyzed for PK values.
Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-6194. AUC0-inf is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to time=infinity. Noncompartmental analysis was used to calculate AUC0-inf for each participant; the portion of the AUC following the last observed concentration was assumed to follow an exponential elimination. Geometric mean and geometric coefficient of variation of AUC0-inf were calculated for each dosing group.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=6 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=5 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=10 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=9 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194
|
899.08 ng*hour/mL
Geometric Coefficient of Variation 36.53
|
2036.51 ng*hour/mL
Geometric Coefficient of Variation 71.46
|
3437.33 ng*hour/mL
Geometric Coefficient of Variation 65.59
|
3169.11 ng*hour/mL
Geometric Coefficient of Variation 120.37
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile.
Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The absolute change in the number of peripheral Tregs in whole blood was assessed.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=3 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
n=9 Participants
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 1
|
16.6 Cells/uL
Geometric Coefficient of Variation 46.10
|
24.0 Cells/uL
Geometric Coefficient of Variation 130.34
|
36.5 Cells/uL
Geometric Coefficient of Variation 76.68
|
31.0 Cells/uL
Geometric Coefficient of Variation 48.95
|
0.0 Cells/uL
Geometric Coefficient of Variation 107.20
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 2
|
15.2 Cells/uL
Geometric Coefficient of Variation 45.43
|
8.4 Cells/uL
Geometric Coefficient of Variation 78.56
|
0.0 Cells/uL
Geometric Coefficient of Variation 84.52
|
29.8 Cells/uL
Geometric Coefficient of Variation 100.53
|
6.0 Cells/uL
Geometric Coefficient of Variation 109.31
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 3
|
12.2 Cells/uL
Geometric Coefficient of Variation 113.83
|
24.5 Cells/uL
Geometric Coefficient of Variation 95.40
|
31.7 Cells/uL
Geometric Coefficient of Variation 92.24
|
15.2 Cells/uL
Geometric Coefficient of Variation 77.36
|
4.4 Cells/uL
Geometric Coefficient of Variation 96.26
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 4
|
5.1 Cells/uL
Geometric Coefficient of Variation 71.20
|
9.5 Cells/uL
Geometric Coefficient of Variation 78.31
|
12.8 Cells/uL
Geometric Coefficient of Variation 82.29
|
4.8 Cells/uL
Geometric Coefficient of Variation 115.02
|
0.0 Cells/uL
Geometric Coefficient of Variation 120.87
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 5
|
33.9 Cells/uL
Geometric Coefficient of Variation 61.55
|
0.0 Cells/uL
Geometric Coefficient of Variation 66.63
|
20.9 Cells/uL
Geometric Coefficient of Variation 78.63
|
35.5 Cells/uL
Geometric Coefficient of Variation 65.56
|
0.0 Cells/uL
Geometric Coefficient of Variation 92.71
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 6
|
9.0 Cells/uL
Geometric Coefficient of Variation 32.73
|
12.9 Cells/uL
Geometric Coefficient of Variation 73.27
|
9.8 Cells/uL
Geometric Coefficient of Variation 100.16
|
18.9 Cells/uL
Geometric Coefficient of Variation 58.45
|
0.0 Cells/uL
Geometric Coefficient of Variation 61.81
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 7
|
4.0 Cells/uL
Geometric Coefficient of Variation 53.29
|
32.3 Cells/uL
Geometric Coefficient of Variation 44.51
|
27.1 Cells/uL
Geometric Coefficient of Variation 69.98
|
7.4 Cells/uL
Geometric Coefficient of Variation 130.11
|
0.0 Cells/uL
Geometric Coefficient of Variation 66.82
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 8
|
3.9 Cells/uL
Geometric Coefficient of Variation 25.00
|
9.4 Cells/uL
Geometric Coefficient of Variation 101.40
|
8.8 Cells/uL
Geometric Coefficient of Variation 62.20
|
7.7 Cells/uL
Geometric Coefficient of Variation 101.49
|
0.0 Cells/uL
Geometric Coefficient of Variation 102.85
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 9
|
6.0 Cells/uL
Geometric Coefficient of Variation 121.24
|
21.1 Cells/uL
Geometric Coefficient of Variation 76.45
|
22.3 Cells/uL
Geometric Coefficient of Variation 83.28
|
42.1 Cells/uL
Geometric Coefficient of Variation 63.99
|
4.3 Cells/uL
Geometric Coefficient of Variation 101.64
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 10
|
2.3 Cells/uL
Geometric Coefficient of Variation 24.74
|
15.4 Cells/uL
Geometric Coefficient of Variation 55.42
|
11.3 Cells/uL
Geometric Coefficient of Variation 76.11
|
16.3 Cells/uL
Geometric Coefficient of Variation 91.23
|
3.5 Cells/uL
Geometric Coefficient of Variation 146.88
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 11
|
—
|
17.8 Cells/uL
Geometric Coefficient of Variation 79.90
|
24.6 Cells/uL
Geometric Coefficient of Variation 82.30
|
—
|
3.5 Cells/uL
Geometric Coefficient of Variation 117.48
|
|
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
Week 12
|
5.9 Cells/uL
Geometric Coefficient of Variation 16.67
|
12.1 Cells/uL
Geometric Coefficient of Variation 56.51
|
6.4 Cells/uL
Geometric Coefficient of Variation 89.54
|
0.0 Cells/uL
Geometric Coefficient of Variation 77.22
|
4.7 Cells/uL
Geometric Coefficient of Variation 91.20
|
SECONDARY outcome
Timeframe: Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile
Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of NK cells in whole blood is presented.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=3 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
n=9 Participants
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 1
|
109.3 Cells/uL
Geometric Coefficient of Variation 117.56
|
0.0 Cells/uL
Geometric Coefficient of Variation 149.43
|
43.2 Cells/uL
Geometric Coefficient of Variation 86.39
|
110.0 Cells/uL
Geometric Coefficient of Variation 61.90
|
34.40 Cells/uL
Geometric Coefficient of Variation 60.38
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 2
|
124.7 Cells/uL
Geometric Coefficient of Variation 83.32
|
76.1 Cells/uL
Geometric Coefficient of Variation 62.77
|
48.6 Cells/uL
Geometric Coefficient of Variation 81.20
|
108.5 Cells/uL
Geometric Coefficient of Variation 55.48
|
19.2 Cells/uL
Geometric Coefficient of Variation 160.68
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 3
|
479.5 Cells/uL
Geometric Coefficient of Variation 85.51
|
50.3 Cells/uL
Geometric Coefficient of Variation 73.79
|
44.2 Cells/uL
Geometric Coefficient of Variation 110.61
|
68.4 Cells/uL
Geometric Coefficient of Variation 62.20
|
64.1 Cells/uL
Geometric Coefficient of Variation 87.37
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 4
|
292.2 Cells/uL
Geometric Coefficient of Variation 48.38
|
52.8 Cells/uL
Geometric Coefficient of Variation 67.48
|
0.0 Cells/uL
Geometric Coefficient of Variation 102.83
|
78.9 Cells/uL
Geometric Coefficient of Variation 73.40
|
42.1 Cells/uL
Geometric Coefficient of Variation 131.09
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 5
|
281.5 Cells/uL
Geometric Coefficient of Variation 27.43
|
42.1 Cells/uL
Geometric Coefficient of Variation 76.34
|
53.8 Cells/uL
Geometric Coefficient of Variation 61.16
|
133.2 Cells/uL
Geometric Coefficient of Variation 87.96
|
65.0 Cells/uL
Geometric Coefficient of Variation 129.61
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 6
|
169.0 Cells/uL
Geometric Coefficient of Variation 88.11
|
59.3 Cells/uL
Geometric Coefficient of Variation 72.56
|
54.7 Cells/uL
Geometric Coefficient of Variation 80.71
|
140.3 Cells/uL
Geometric Coefficient of Variation 78.10
|
55.3 Cells/uL
Geometric Coefficient of Variation 124.75
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 7
|
224.8 Cells/uL
Geometric Coefficient of Variation 83.09
|
0.0 Cells/uL
Geometric Coefficient of Variation 112.85
|
73.2 Cells/uL
Geometric Coefficient of Variation 66.16
|
82.0 Cells/uL
Geometric Coefficient of Variation 93.62
|
44.9 Cells/uL
Geometric Coefficient of Variation 119.10
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 8
|
272.9 Cells/uL
Geometric Coefficient of Variation 54.62
|
38.4 Cells/uL
Geometric Coefficient of Variation 113.46
|
43.7 Cells/uL
Geometric Coefficient of Variation 148.37
|
86.9 Cells/uL
Geometric Coefficient of Variation 49.10
|
30.4 Cells/uL
Geometric Coefficient of Variation 125.05
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 9
|
195.5 Cells/uL
Geometric Coefficient of Variation 4.35
|
92.8 Cells/uL
Geometric Coefficient of Variation 94.04
|
72.8 Cells/uL
Geometric Coefficient of Variation 74.20
|
94.0 Cells/uL
Geometric Coefficient of Variation 75.86
|
53.2 Cells/uL
Geometric Coefficient of Variation 81.75
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 10
|
159.6 Cells/uL
Geometric Coefficient of Variation 59.86
|
26.4 Cells/uL
Geometric Coefficient of Variation 83.25
|
46.0 Cells/uL
Geometric Coefficient of Variation 111.12
|
87.1 Cells/uL
Geometric Coefficient of Variation 99.38
|
84.5 Cells/uL
Geometric Coefficient of Variation 91.34
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 11
|
—
|
42.3 Cells/uL
Geometric Coefficient of Variation 94.19
|
47.0 Cells/uL
Geometric Coefficient of Variation 91.92
|
—
|
41.1 Cells/uL
Geometric Coefficient of Variation 163.74
|
|
Change in Number of Natural Killer (NK) Cells in Whole Blood
Week 12
|
70.6 Cells/uL
Geometric Coefficient of Variation 125.61
|
67.6 Cells/uL
Geometric Coefficient of Variation 60.56
|
58.4 Cells/uL
Geometric Coefficient of Variation 84.39
|
45.6 Cells/uL
Geometric Coefficient of Variation 119.58
|
40.9 Cells/uL
Geometric Coefficient of Variation 121.60
|
SECONDARY outcome
Timeframe: Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile
Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of Tcons in whole blood is presented.
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=3 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=18 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=10 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
n=9 Participants
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 1
|
216.9 Cells/uL
Geometric Coefficient of Variation 94.52
|
220.8 Cells/uL
Geometric Coefficient of Variation 94.37
|
91.2 Cells/uL
Geometric Coefficient of Variation 105.12
|
189.6 Cells/uL
Geometric Coefficient of Variation 66.58
|
57.6 Cells/uL
Geometric Coefficient of Variation 79.00
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 2
|
106.1 Cells/uL
Geometric Coefficient of Variation 124.15
|
100.8 Cells/uL
Geometric Coefficient of Variation 67.50
|
105.4 Cells/uL
Geometric Coefficient of Variation 121.23
|
184.1 Cells/uL
Geometric Coefficient of Variation 67.77
|
0.0 Cells/uL
Geometric Coefficient of Variation 71.58
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 3
|
347.3 Cells/uL
Geometric Coefficient of Variation 129.76
|
81.1 Cells/uL
Geometric Coefficient of Variation 98.95
|
123.7 Cells/uL
Geometric Coefficient of Variation 111.06
|
192.8 Cells/uL
Geometric Coefficient of Variation 60.55
|
127.7 Cells/uL
Geometric Coefficient of Variation 52.96
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 4
|
280.2 Cells/uL
Geometric Coefficient of Variation 116.12
|
122.4 Cells/uL
Geometric Coefficient of Variation 61.71
|
73.3 Cells/uL
Geometric Coefficient of Variation 108.47
|
163.4 Cells/uL
Geometric Coefficient of Variation 72.06
|
63.3 Cells/uL
Geometric Coefficient of Variation 105.58
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 5
|
456.3 Cells/uL
Geometric Coefficient of Variation 28.23
|
100.6 Cells/uL
Geometric Coefficient of Variation 74.36
|
126.2 Cells/uL
Geometric Coefficient of Variation 75.69
|
166.8 Cells/uL
Geometric Coefficient of Variation 76.19
|
79.3 Cells/uL
Geometric Coefficient of Variation 66.49
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 6
|
114.3 Cells/uL
Geometric Coefficient of Variation 119.18
|
57.9 Cells/uL
Geometric Coefficient of Variation 101.25
|
0.0 Cells/uL
Geometric Coefficient of Variation 101.48
|
193.9 Cells/uL
Geometric Coefficient of Variation 68.59
|
53.8 Cells/uL
Geometric Coefficient of Variation 90.84
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 7
|
137.7 Cells/uL
Geometric Coefficient of Variation 84.27
|
103.6 Cells/uL
Geometric Coefficient of Variation 68.22
|
68.6 Cells/uL
Geometric Coefficient of Variation 87.88
|
154.5 Cells/uL
Geometric Coefficient of Variation 70.64
|
66.1 Cells/uL
Geometric Coefficient of Variation 87.17
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 8
|
381.1 Cells/uL
Geometric Coefficient of Variation 34.64
|
109.0 Cells/uL
Geometric Coefficient of Variation 84.28
|
63.5 Cells/uL
Geometric Coefficient of Variation 82.18
|
159.1 Cells/uL
Geometric Coefficient of Variation 66.12
|
50.6 Cells/uL
Geometric Coefficient of Variation 93.80
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 9
|
250.3 Cells/uL
Geometric Coefficient of Variation 39.38
|
164.1 Cells/uL
Geometric Coefficient of Variation 51.01
|
128.8 Cells/uL
Geometric Coefficient of Variation 89.61
|
192.2 Cells/uL
Geometric Coefficient of Variation 71.43
|
141.5 Cells/uL
Geometric Coefficient of Variation 63.25
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 10
|
271.1 Cells/uL
Geometric Coefficient of Variation 81.50
|
33.4 Cells/uL
Geometric Coefficient of Variation 115.44
|
50.7 Cells/uL
Geometric Coefficient of Variation 98.06
|
147.3 Cells/uL
Geometric Coefficient of Variation 72.31
|
83.2 Cells/uL
Geometric Coefficient of Variation 92.61
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 11
|
—
|
76.1 Cells/uL
Geometric Coefficient of Variation 59.20
|
90.5 Cells/uL
Geometric Coefficient of Variation 80.69
|
—
|
102.0 Cells/uL
Geometric Coefficient of Variation 45.66
|
|
Change in Number of Conventional T Cells (Tcons) in Whole Blood
Week 12
|
122.6 Cells/uL
Geometric Coefficient of Variation 134.20
|
73.2 Cells/uL
Geometric Coefficient of Variation 96.94
|
99.9 Cells/uL
Geometric Coefficient of Variation 77.32
|
153.3 Cells/uL
Geometric Coefficient of Variation 70.03
|
73.4 Cells/uL
Geometric Coefficient of Variation 82.45
|
SECONDARY outcome
Timeframe: Pre dose (week 0) and Weeks 4, 8, 12Population: All randomized participants who received at least 1 dose of study intervention and who had least 1 valid analytical result at baseline, at least 1 post-dose analytical result and had no major relevant protocol or dosing deviations that could potentially affect the pharmacodynamic profile. ADA titer was assessed only in participants who were ADA positive.
Blood samples were collected for the determination of ADA to MK-6194 using a screening assay, ADA titer using a confirmatory assay, and neutralizing antibody to MK-6194 in participants with confirmed positive titers
Outcome measures
| Measure |
MK-6194 Low Dose - Interval 1 (Less Frequent)
n=1 Participants
Participants received low dose of MK-6194 at specified less frequent intervals test
|
MK-6194 Medium Dose- Interval 2 (More Frequent)
n=5 Participants
Participants received medium dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 2 (More Frequent)
n=8 Participants
Participants received high dose of MK-6194 at specified more frequent intervals
|
MK-6194 High Dose - Interval 1 (Less Frequent)
n=7 Participants
Participants received high dose MK-6194 at specified less frequent intervals
|
Placebo
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
|
|---|---|---|---|---|---|
|
Titer of Anti-drug Antibody (ADA) to MK-6194
Week 0
|
—
|
20.0 Titer
Interval 20.0 to 20.0
|
—
|
20.0 Titer
Interval 20.0 to 20.0
|
—
|
|
Titer of Anti-drug Antibody (ADA) to MK-6194
Week 4
|
—
|
20.0 Titer
Interval 20.0 to 20.0
|
20.0 Titer
Interval 20.0 to 20.0
|
20.0 Titer
Interval 20.0 to 160.0
|
—
|
|
Titer of Anti-drug Antibody (ADA) to MK-6194
Week 8
|
160.0 Titer
Interval 160.0 to 160.0
|
20.0 Titer
Interval 20.0 to 20.0
|
20.0 Titer
Interval 20.0 to 20.0
|
20.0 Titer
Interval 20.0 to 40.0
|
—
|
|
Titer of Anti-drug Antibody (ADA) to MK-6194
Week 12
|
640.0 Titer
Interval 640.0 to 640.0
|
40.0 Titer
Interval 20.0 to 320.0
|
20.0 Titer
Interval 20.0 to 640.0
|
40.0 Titer
Interval 20.0 to 160.0
|
—
|
Adverse Events
IBT: MK-6194 Low Dose Interval 1 (Less Frequent)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
IBT-MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
IBT: MK-6194 High Dose-Interval 2 (More Frequent)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
IBT:MK-6194 High Dose-Interval 1 (Less Frequent)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
IBT: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CBT: MK-6194 Low Dose- Interval 1 (Less Frequent)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CBT: MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CBT: MK-6194 High Dose- Interval 2 (More Frequent)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CBT: MK-6194 High Dose - Interval 1 (Less Frequent)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CBT: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OL: MK-6194 Low Dose -Interval 1 (Less Frequent)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OL: MK-6194 Medium Dose- Interval 2 (More Frequent)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OL: MK-6194 High Dose- Interval 2 (More Frequent)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IBT: MK-6194 Low Dose Interval 1 (Less Frequent)
n=7 participants at risk
Participants received low dose MK-6194 at specified less frequent intervals for up to 12 weeks
|
IBT-MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 participants at risk
Participants received medium dose of MK-6194 at specified more frequent intervals for up to 12 weeks
|
IBT: MK-6194 High Dose-Interval 2 (More Frequent)
n=18 participants at risk
Participants received high dose of MK-6194 at specified more frequent intervals for up to 12 weeks
|
IBT:MK-6194 High Dose-Interval 1 (Less Frequent)
n=10 participants at risk
Participants received high dose MK-6194 at specified less frequent intervals for up to 12 weeks
|
IBT: Placebo
n=11 participants at risk
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2 for up to 12 weeks
|
CBT: MK-6194 Low Dose- Interval 1 (Less Frequent)
n=2 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive low dose MK-6194 at specified less frequent intervals for up to 9 months
|
CBT: MK-6194 Medium Dose- Interval 2 (More Frequent)
n=1 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive medium dose MK-6194 at specified more frequent intervals for up to 9 months
|
CBT: MK-6194 High Dose- Interval 2 (More Frequent)
n=2 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive high dose MK-6194 at specified more frequent intervals for up to 9 months
|
CBT: MK-6194 High Dose - Interval 1 (Less Frequent)
n=3 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive high dose MK-6194 at specified less frequent intervals for up to 9 months
|
CBT: Placebo
n=3 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive placebo at interval 1 or 2 for up to 9 months
|
OL: MK-6194 Low Dose -Interval 1 (Less Frequent)
n=3 participants at risk
Participants who did not achieve clinical response at week 12 received low dose MK-6194 at specified less frequent intervals for up to 9 months
|
OL: MK-6194 Medium Dose- Interval 2 (More Frequent)
n=4 participants at risk
Participants who did not achieve clinical response at week 12 received medium dose MK-6194 at specified more frequent intervals for up to 9 months
|
OL: MK-6194 High Dose- Interval 2 (More Frequent)
n=4 participants at risk
Participants who did not achieve clinical response at week 12 received high dose MK-6194 at specified more frequent intervals for up to 9 months
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
Other adverse events
| Measure |
IBT: MK-6194 Low Dose Interval 1 (Less Frequent)
n=7 participants at risk
Participants received low dose MK-6194 at specified less frequent intervals for up to 12 weeks
|
IBT-MK-6194 Medium Dose- Interval 2 (More Frequent)
n=11 participants at risk
Participants received medium dose of MK-6194 at specified more frequent intervals for up to 12 weeks
|
IBT: MK-6194 High Dose-Interval 2 (More Frequent)
n=18 participants at risk
Participants received high dose of MK-6194 at specified more frequent intervals for up to 12 weeks
|
IBT:MK-6194 High Dose-Interval 1 (Less Frequent)
n=10 participants at risk
Participants received high dose MK-6194 at specified less frequent intervals for up to 12 weeks
|
IBT: Placebo
n=11 participants at risk
Participants received MK-6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2 for up to 12 weeks
|
CBT: MK-6194 Low Dose- Interval 1 (Less Frequent)
n=2 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive low dose MK-6194 at specified less frequent intervals for up to 9 months
|
CBT: MK-6194 Medium Dose- Interval 2 (More Frequent)
n=1 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive medium dose MK-6194 at specified more frequent intervals for up to 9 months
|
CBT: MK-6194 High Dose- Interval 2 (More Frequent)
n=2 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive high dose MK-6194 at specified more frequent intervals for up to 9 months
|
CBT: MK-6194 High Dose - Interval 1 (Less Frequent)
n=3 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive high dose MK-6194 at specified less frequent intervals for up to 9 months
|
CBT: Placebo
n=3 participants at risk
Participants who achieved clinical response at week 12 of the IBT continued to receive placebo at interval 1 or 2 for up to 9 months
|
OL: MK-6194 Low Dose -Interval 1 (Less Frequent)
n=3 participants at risk
Participants who did not achieve clinical response at week 12 received low dose MK-6194 at specified less frequent intervals for up to 9 months
|
OL: MK-6194 Medium Dose- Interval 2 (More Frequent)
n=4 participants at risk
Participants who did not achieve clinical response at week 12 received medium dose MK-6194 at specified more frequent intervals for up to 9 months
|
OL: MK-6194 High Dose- Interval 2 (More Frequent)
n=4 participants at risk
Participants who did not achieve clinical response at week 12 received high dose MK-6194 at specified more frequent intervals for up to 9 months
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
2/7 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
42.9%
3/7 • Number of events 4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
63.6%
7/11 • Number of events 26 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
94.4%
17/18 • Number of events 50 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
40.0%
4/10 • Number of events 8 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
18.2%
2/11 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
100.0%
1/1 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
33.3%
1/3 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
33.3%
1/3 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
75.0%
3/4 • Number of events 5 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
25.0%
1/4 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
11.1%
2/18 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
20.0%
2/10 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
20.0%
2/10 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site discolouration
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site erythema
|
71.4%
5/7 • Number of events 13 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
63.6%
7/11 • Number of events 19 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
66.7%
12/18 • Number of events 39 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
5/10 • Number of events 8 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
100.0%
2/2 • Number of events 5 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
100.0%
1/1 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
100.0%
2/2 • Number of events 6 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
33.3%
1/3 • Number of events 5 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
33.3%
1/3 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
2/4 • Number of events 5 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site induration
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
16.7%
3/18 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site oedema
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
16.7%
3/18 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site pain
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site pruritus
|
28.6%
2/7 • Number of events 4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
36.4%
4/11 • Number of events 4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
11.1%
2/18 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
33.3%
1/3 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site rash
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
General disorders
Injection site swelling
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
11.1%
2/18 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
20.0%
2/10 • Number of events 5 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
50.0%
1/2 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
25.0%
1/4 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Investigations
Weight increased
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
33.3%
1/3 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
11.1%
2/18 • Number of events 2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
9.1%
1/11 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Psychiatric disorders
Dermatillomania
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
5.6%
1/18 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/10 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/18 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
10.0%
1/10 • Number of events 1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/11 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/1 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/2 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/3 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
0.00%
0/4 • Up to approximately 52 weeks
The population consists of all participants who received at least one dose of study drug. Treatment groups use the actual treatment received, regardless of randomization assignment. Per protocol, participants receiving placebo in IBT phase and not achieving clinical response could enter the OL phase to receive the matching MK-6194 regimen from their IBT cohort. Participants receiving placebo in IBT phase and achieving clinical response could enter the CBT phase and continue receiving placebo.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator will submit the proposed publication to the sponsor at least 30 days prior to the date of submission for publication. The sponsor can request to remove any confidential information other than study data from a proposed publication during the review period. The sponsor may also suggest changes to the presentation of study data and timing of the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER