Trial Outcomes & Findings for Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT05268016)
NCT ID: NCT05268016
Last Updated: 2024-06-27
Results Overview
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Week 16
Results posted on
2024-06-27
Participant Flow
The study started to enroll participants in March 2022 and concluded in May 2023.
Participant milestones
| Measure |
ME3183 Dose 1, BID
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
26
|
27
|
27
|
|
Overall Study
COMPLETED
|
17
|
14
|
18
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
8
|
12
|
11
|
Reasons for withdrawal
| Measure |
ME3183 Dose 1, BID
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Unacceptable toxicity or AE
|
2
|
2
|
4
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
1
|
3
|
5
|
|
Overall Study
Patient fails to adhere to the major protocol requirements
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
ME3183 Dose 1, BID
n=26 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=27 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 15.19 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 14.60 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 13.38 • n=4 Participants
|
45.5 years
STANDARD_DEVIATION 16.54 • n=21 Participants
|
46.3 years
STANDARD_DEVIATION 14.14 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
84 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
105 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
111 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the Full analysis set (FAS).
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than or Equal to (>=) 75% Reduction From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16
|
58.3 percentage of participants
Interval 36.6 to 77.9
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
SECONDARY outcome
Timeframe: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)Population: All randomized participants who received at least 1 dose of study drug were included in the Safety Analysis Set (SAS). Analyses in the SAS were based on the study treatment received by each participant.
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. A Treatment-Emergent Adverse Event (TEAE) is an AE that occurred during the study after the first dose of study drug or that was present prior to dosing and exacerbates after the first dose of study drug.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=25 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period
|
16 Participants
|
17 Participants
|
23 Participants
|
24 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)Population: All randomized participants who received at least 1 dose of study drug were included in the SAS. Analyses in the SAS were based on the study treatment received by each participant.
An SAE is any untoward medical occurrence, in the view of either the investigator or Sponsor, that: * results in death, * is life-threatening, * results in inpatient hospitalization or prolongation of existing hospitalization, * results in persistent or significant disability/incapacity, and/or * is a congenital anomaly/birth defect. Other important medical events that may not be immediately life-threatening or result in death or hospitalization, based upon appropriate medical judgement, are considered SAEs if they are thought to jeopardize the subject and/or require medical or surgical intervention to prevent one of the outcomes defining an SAE.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=25 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)Population: All randomized participants who received at least 1 dose of study drug were included in the SAS. Analyses in the SAS were based on the study treatment received by each participant.
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. AEs were classified by severity as follows: MILD: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. MODERATE: An event that is sufficiently discomforting to interfere with normal everyday activities. SEVERE: An event that prevents normal everyday activities.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=25 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period
Mild
|
7 Participants
|
11 Participants
|
8 Participants
|
15 Participants
|
11 Participants
|
|
Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period
Moderate
|
9 Participants
|
5 Participants
|
14 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period
Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)Population: All randomized participants who received at least 1 dose of study drug were included in the SAS. Analyses in the SAS were based on the study treatment received by each participant.
Physical Examination included height and body mass index. Any change in Physical examination abnormalities that were deemed clinically significant by the investigator were recorded as TEAEs.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=25 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)Population: All randomized participants who received at least 1 dose of study drug were included in the SAS. Analyses in the SAS were based on the study treatment received by each participant.
Vital signs parameters included blood pressure, heart rate, respiratory rate, body temperature, and body weight. Any change in vital sign abnormalities that were deemed clinically significant by the investigator were recorded as TEAEs.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=25 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)Population: All randomized participants who received at least 1 dose of study drug were included in the SAS. Analyses in the SAS were based on the study treatment received by each participant.
Clinical laboratory testing included electrocardiogram (ECG), hematology, coagulation, blood chemistry, and urinalysis. Any change in clinical laboratory abnormalities that were deemed clinically significant by the investigator were recorded as TEAEs.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=25 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Here, Number analyzed signifies participants who were evaluable at specified time points.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). Total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by constant. Scores for each anatomic region are combined to yield final PASI score (0 to 72). Higher scores= greater disease severity. Negative change from baseline indicates an improvement of disease symptoms. Percent reduction= (PASI score at Baseline - score at a follow-up visit) / PASI score at Baseline \* 100.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=23 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=24 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=23 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
At Week 1
|
-22.87 percent change
Standard Deviation 22.870
|
-15.39 percent change
Standard Deviation 21.708
|
-24.47 percent change
Standard Deviation 20.202
|
-26.93 percent change
Standard Deviation 26.966
|
-12.01 percent change
Standard Deviation 23.583
|
|
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
At Week 2
|
-42.41 percent change
Standard Deviation 27.717
|
-26.26 percent change
Standard Deviation 24.172
|
-41.91 percent change
Standard Deviation 29.573
|
-42.59 percent change
Standard Deviation 24.412
|
-18.44 percent change
Standard Deviation 19.503
|
|
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
At Week 4
|
-47.82 percent change
Standard Deviation 28.580
|
-40.06 percent change
Standard Deviation 30.657
|
-56.77 percent change
Standard Deviation 34.835
|
-54.44 percent change
Standard Deviation 26.596
|
-21.55 percent change
Standard Deviation 27.031
|
|
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
At Week 8
|
-66.38 percent change
Standard Deviation 25.175
|
-55.75 percent change
Standard Deviation 28.436
|
-83.31 percent change
Standard Deviation 18.738
|
-72.19 percent change
Standard Deviation 22.642
|
-24.17 percent change
Standard Deviation 29.730
|
|
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
At Week 12
|
-72.31 percent change
Standard Deviation 24.622
|
-61.92 percent change
Standard Deviation 29.350
|
-87.22 percent change
Standard Deviation 14.863
|
-79.60 percent change
Standard Deviation 18.063
|
-36.18 percent change
Standard Deviation 40.257
|
|
Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
At Week 16
|
-74.77 percent change
Standard Deviation 26.079
|
-71.38 percent change
Standard Deviation 25.923
|
-90.77 percent change
Standard Deviation 14.941
|
-86.96 percent change
Standard Deviation 12.414
|
-40.26 percent change
Standard Deviation 40.299
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
At Week 1
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
7.7 percentage of participants
Interval 0.9 to 25.1
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
|
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
At Week 2
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
|
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
At Week 4
|
50.0 percentage of participants
Interval 29.1 to 70.9
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
56.0 percentage of participants
Interval 34.9 to 75.6
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
|
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
At Week 8
|
58.3 percentage of participants
Interval 36.6 to 77.9
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
69.2 percentage of participants
Interval 48.2 to 85.7
|
64.0 percentage of participants
Interval 42.5 to 82.0
|
22.2 percentage of participants
Interval 8.6 to 42.3
|
|
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
At Week 12
|
70.8 percentage of participants
Interval 48.9 to 87.4
|
56.0 percentage of participants
Interval 34.9 to 75.6
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
64.0 percentage of participants
Interval 42.5 to 82.0
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
|
Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
At Week 16
|
75.0 percentage of participants
Interval 53.3 to 90.2
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
65.4 percentage of participants
Interval 44.3 to 82.8
|
60.0 percentage of participants
Interval 38.7 to 78.9
|
29.6 percentage of participants
Interval 13.8 to 50.2
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
At Week 1
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 13.2
|
4.0 percentage of participants
Interval 0.1 to 20.4
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
At Week 2
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
At Week 4
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
|
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
At Week 8
|
41.7 percentage of participants
Interval 22.1 to 63.4
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
|
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
At Week 12
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
57.7 percentage of participants
Interval 36.9 to 76.6
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
|
Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
At Week 16
|
58.3 percentage of participants
Interval 36.6 to 77.9
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
At Week 1
|
0 percentage of participants
Interval 0.0 to 14.2
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 13.2
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
At Week 2
|
0 percentage of participants
Interval 0.0 to 14.2
|
4.0 percentage of participants
Interval 0.1 to 20.4
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
At Week 4
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
7.7 percentage of participants
Interval 0.9 to 25.1
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
At Week 8
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
At Week 12
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
|
Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
At Week 16
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
28.0 percentage of participants
Interval 12.1 to 49.4
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
At Week 1
|
0 percentage of participants
Interval 0.0 to 14.2
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 13.2
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
At Week 2
|
0 percentage of participants
Interval 0.0 to 14.2
|
4.0 percentage of participants
Interval 0.1 to 20.4
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
At Week 4
|
0 percentage of participants
Interval 0.0 to 14.2
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
At Week 8
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
At Week 12
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
At Week 16
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
26.9 percentage of participants
Interval 11.6 to 47.8
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
0 percentage of participants
Interval 0.0 to 12.8
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
Time to the first response of PASI-50 was defined as the number of days from the first dose of the study drug to the first response.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Time to PASI-50
|
33.5 days
Interval 16.0 to 57.0
|
57.0 days
Interval 29.0 to 86.0
|
28.0 days
Interval 16.0 to 29.0
|
29.0 days
Interval 15.0 to 43.0
|
113.0 days
Interval 55.0 to
Upper limit of 95% CI was not calculated due to less number of events.
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
Time to the first response of PASI-75 was defined as the number of days from the first dose of the study drug to the first response.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Time to PASI-75
|
58.0 days
Interval 55.0 to 111.0
|
NA days
Interval 57.0 to
Median and Upper limit of 95% CI were not calculated due to less number of events.
|
56.0 days
Interval 29.0 to 61.0
|
57.0 days
Interval 49.0 to 81.0
|
NA days
Interval 112.0 to
Median and Upper limit of 95% CI were not calculated due to less number of events.
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
The Percentage of participants who achieved the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) combined with 2-point reduction on the 5-point sPGA scale were reported. The investigator rated the severity of participant's psoriasis on the 5-point scale ranging from 0 (clear) to 4 (severe). 0 = Clear: No signs of psoriasis. Post-inflammatory hyperpigmentation may be present. 1. = Almost clear: Normal to pink coloration of lesions; no thickening; no to minimal focal scaling. 2. = Mild: Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling. 3= Moderate: Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling. 4 = Severe: Bright to deep dark red coloration; severe thickening with hard edges; severe/coarse scaling covering almost all or all lesions. Missing values are imputed as non-responders via NRI.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16
At Week 1
|
0 percentage of participants
Interval 0.0 to 14.2
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 13.2
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16
At Week 2
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
4.0 percentage of participants
Interval 0.1 to 20.4
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16
At Week 4
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16
At Week 8
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
38.5 percentage of participants
Interval 20.2 to 59.4
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
0 percentage of participants
Interval 0.0 to 12.8
|
|
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16
At Week 12
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
28.0 percentage of participants
Interval 12.1 to 49.4
|
42.3 percentage of participants
Interval 23.4 to 63.1
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
|
Percentage of Participants Achieving a Static Physicians Global Assessment (sPGA) Score of "0" ("Clear") or "1" ("Almost Clear") Combined With 2-point Reduction on the 5-point sPGA Scale at All Visits From Week 1 to Week 16
At Week 16
|
33.3 percentage of participants
Interval 15.6 to 55.3
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
28.0 percentage of participants
Interval 12.1 to 49.4
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
BSA is a measurement of the affected skin area. The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
At Week 1
|
-1.6 percentage of body surface area
Interval -3.9 to 0.7
|
-2.1 percentage of body surface area
Interval -4.3 to 0.1
|
-3.6 percentage of body surface area
Interval -5.8 to -1.4
|
-3.5 percentage of body surface area
Interval -5.7 to -1.2
|
-0.8 percentage of body surface area
Interval -2.9 to 1.3
|
|
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
At Week 2
|
-5.6 percentage of body surface area
Interval -8.2 to -2.9
|
-3.6 percentage of body surface area
Interval -6.2 to -1.1
|
-6.7 percentage of body surface area
Interval -9.3 to -4.1
|
-4.7 percentage of body surface area
Interval -7.2 to -2.1
|
-1.9 percentage of body surface area
Interval -4.4 to 0.5
|
|
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
At Week 4
|
-6.9 percentage of body surface area
Interval -9.8 to -4.0
|
-6.2 percentage of body surface area
Interval -9.1 to -3.4
|
-9.5 percentage of body surface area
Interval -12.4 to -6.7
|
-7.3 percentage of body surface area
Interval -10.1 to -4.4
|
-2.6 percentage of body surface area
Interval -5.4 to 0.2
|
|
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
At Week 8
|
-12.2 percentage of body surface area
Interval -15.6 to -8.7
|
-9.0 percentage of body surface area
Interval -12.4 to -5.7
|
-15.3 percentage of body surface area
Interval -18.7 to -11.8
|
-11.8 percentage of body surface area
Interval -15.1 to -8.4
|
-3.6 percentage of body surface area
Interval -6.8 to -0.4
|
|
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
At Week 12
|
-15.1 percentage of body surface area
Interval -18.8 to -11.4
|
-11.9 percentage of body surface area
Interval -15.5 to -8.3
|
-16.7 percentage of body surface area
Interval -20.5 to -12.9
|
-12.9 percentage of body surface area
Interval -16.6 to -9.3
|
-4.4 percentage of body surface area
Interval -8.0 to -0.9
|
|
Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
At Week 16
|
-16.4 percentage of body surface area
Interval -20.4 to -12.4
|
-12.1 percentage of body surface area
Interval -16.1 to -8.0
|
-17.3 percentage of body surface area
Interval -21.4 to -13.1
|
-14.4 percentage of body surface area
Interval -18.6 to -10.3
|
-7.6 percentage of body surface area
Interval -11.6 to -3.6
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." The overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
At Week 1
|
-1.7 score on a scale
Interval -2.6 to -0.8
|
-1.5 score on a scale
Interval -2.3 to -0.6
|
-2.7 score on a scale
Interval -3.5 to -1.8
|
-2.3 score on a scale
Interval -3.2 to -1.5
|
-1.2 score on a scale
Interval -2.0 to -0.4
|
|
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
At Week 2
|
-3.3 score on a scale
Interval -4.3 to -2.3
|
-2.1 score on a scale
Interval -3.0 to -1.2
|
-3.0 score on a scale
Interval -3.9 to -2.1
|
-3.3 score on a scale
Interval -4.2 to -2.4
|
-0.7 score on a scale
Interval -1.6 to 0.2
|
|
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
At Week 4
|
-2.9 score on a scale
Interval -4.0 to -1.8
|
-2.7 score on a scale
Interval -3.8 to -1.7
|
-3.9 score on a scale
Interval -4.9 to -2.8
|
-3.7 score on a scale
Interval -4.8 to -2.7
|
-0.5 score on a scale
Interval -1.5 to 0.5
|
|
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
At Week 8
|
-4.0 score on a scale
Interval -5.1 to -2.9
|
-3.6 score on a scale
Interval -4.6 to -2.6
|
-4.6 score on a scale
Interval -5.7 to -3.6
|
-4.4 score on a scale
Interval -5.4 to -3.4
|
-1.0 score on a scale
Interval -2.0 to 0.0
|
|
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
At Week 12
|
-4.4 score on a scale
Interval -5.5 to -3.3
|
-3.9 score on a scale
Interval -4.9 to -2.8
|
-4.9 score on a scale
Interval -6.0 to -3.8
|
-4.0 score on a scale
Interval -5.1 to -3.0
|
-1.4 score on a scale
Interval -2.5 to -0.4
|
|
Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
At Week 16
|
-4.8 score on a scale
Interval -5.9 to -3.7
|
-3.9 score on a scale
Interval -5.0 to -2.8
|
-5.0 score on a scale
Interval -6.1 to -3.9
|
-4.5 score on a scale
Interval -5.6 to -3.3
|
-1.4 score on a scale
Interval -2.5 to -0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS.
DLQI is a 10-item questionnaire that measures the impact of skin disease on a participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI a total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on the quality of life of participants. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=24 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=25 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
At Week 1
|
-2.2 score on a scale
Interval -4.2 to -0.3
|
-2.4 score on a scale
Interval -4.2 to -0.5
|
-5.0 score on a scale
Interval -6.8 to -3.2
|
-3.3 score on a scale
Interval -5.1 to -1.4
|
-4.1 score on a scale
Interval -5.8 to -2.4
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
At Week 2
|
-5.1 score on a scale
Interval -7.0 to -3.1
|
-5.6 score on a scale
Interval -7.5 to -3.8
|
-6.2 score on a scale
Interval -8.0 to -4.3
|
-5.5 score on a scale
Interval -7.3 to -3.6
|
-3.4 score on a scale
Interval -5.2 to -1.6
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
At Week 4
|
-5.2 score on a scale
Interval -7.4 to -3.0
|
-6.0 score on a scale
Interval -8.2 to -3.9
|
-8.1 score on a scale
Interval -10.2 to -6.0
|
-6.4 score on a scale
Interval -8.5 to -4.2
|
-3.4 score on a scale
Interval -5.5 to -1.4
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
At Week 8
|
-6.9 score on a scale
Interval -9.1 to -4.7
|
-6.4 score on a scale
Interval -8.5 to -4.2
|
-8.8 score on a scale
Interval -11.0 to -6.6
|
-8.0 score on a scale
Interval -10.2 to -5.9
|
-4.0 score on a scale
Interval -6.1 to -2.0
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
At Week 12
|
-7.8 score on a scale
Interval -10.1 to -5.6
|
-6.2 score on a scale
Interval -8.4 to -4.1
|
-9.5 score on a scale
Interval -11.7 to -7.2
|
-8.9 score on a scale
Interval -11.1 to -6.7
|
-3.6 score on a scale
Interval -5.7 to -1.5
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
At Week 16
|
-8.3 score on a scale
Interval -10.3 to -6.3
|
-6.9 score on a scale
Interval -8.9 to -5.0
|
-9.6 score on a scale
Interval -11.5 to -7.6
|
-9.5 score on a scale
Interval -11.5 to -7.5
|
-3.7 score on a scale
Interval -5.7 to -1.8
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16Population: All participants who had been randomized, received at least 1 dose of the study drug and had at least 1 evaluable postbaseline time point were included in the FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Here, number analyzed signifies participants who were evaluable at specified time points.
DLQI is a 10-item questionnaire that measures the impact of skin disease on a participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI a total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on the quality of life of participants.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=22 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=24 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=23 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=25 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 Participants
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
At Week 1
|
22.7 percentage of participants
Interval 7.8 to 45.4
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
65.2 percentage of participants
Interval 42.7 to 83.6
|
36.4 percentage of participants
Interval 17.2 to 59.3
|
44.4 percentage of participants
Interval 25.5 to 64.7
|
|
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
At Week 2
|
52.4 percentage of participants
Interval 29.8 to 74.3
|
41.7 percentage of participants
Interval 22.1 to 63.4
|
63.6 percentage of participants
Interval 40.7 to 82.8
|
56.0 percentage of participants
Interval 34.9 to 75.6
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
|
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
At Week 4
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
41.7 percentage of participants
Interval 22.1 to 63.4
|
60.9 percentage of participants
Interval 38.5 to 80.3
|
56.5 percentage of participants
Interval 34.5 to 76.8
|
40.0 percentage of participants
Interval 21.1 to 61.3
|
|
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
At Week 8
|
60.0 percentage of participants
Interval 36.1 to 80.9
|
47.6 percentage of participants
Interval 25.7 to 70.2
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
|
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
At Week 12
|
55.0 percentage of participants
Interval 31.5 to 76.9
|
50.0 percentage of participants
Interval 27.2 to 72.8
|
82.4 percentage of participants
Interval 56.6 to 96.2
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
42.1 percentage of participants
Interval 20.3 to 66.5
|
|
Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
At Week 16
|
60.0 percentage of participants
Interval 36.1 to 80.9
|
58.8 percentage of participants
Interval 32.9 to 81.6
|
77.8 percentage of participants
Interval 52.4 to 93.6
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
35.3 percentage of participants
Interval 14.2 to 61.7
|
SECONDARY outcome
Timeframe: Pre-dose at Week 1, 4, 8 and 16Population: The PK analysis set consisted of all participants who were correctly administered at least 1 ME3183 dose and where ME3183 concentration data is available without any protocol deviation interfering with these results. Analyses in PK analysis set was based on the study treatment actually received by each participant. Here, number of participants analyzed= participants who were evaluable for this outcome measure. Number analyzed= participants who were evaluable at specified time points.
Ctrough of study drug was determined from the plasma samples using a validated analytical method.
Outcome measures
| Measure |
ME3183 Dose 1, BID
n=19 Participants
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=18 Participants
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=18 Participants
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=18 Participants
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of ME3183
At Week 1
|
13998.33 nanograms per liter (ng/L)
Geometric Coefficient of Variation 88.57
|
11491.05 nanograms per liter (ng/L)
Geometric Coefficient of Variation 82.48
|
28559.81 nanograms per liter (ng/L)
Geometric Coefficient of Variation 55.62
|
21229.09 nanograms per liter (ng/L)
Geometric Coefficient of Variation 78.54
|
—
|
|
Trough Serum Concentration (Ctrough) of ME3183
At Week 4
|
17973.10 nanograms per liter (ng/L)
Geometric Coefficient of Variation 53.45
|
16522.41 nanograms per liter (ng/L)
Geometric Coefficient of Variation 63.92
|
24920.33 nanograms per liter (ng/L)
Geometric Coefficient of Variation 139.68
|
25396.74 nanograms per liter (ng/L)
Geometric Coefficient of Variation 102.98
|
—
|
|
Trough Serum Concentration (Ctrough) of ME3183
At Week 8
|
14606.67 nanograms per liter (ng/L)
Geometric Coefficient of Variation 49.37
|
13046.98 nanograms per liter (ng/L)
Geometric Coefficient of Variation 73.86
|
27970.28 nanograms per liter (ng/L)
Geometric Coefficient of Variation 82.55
|
16320.92 nanograms per liter (ng/L)
Geometric Coefficient of Variation 162.08
|
—
|
|
Trough Serum Concentration (Ctrough) of ME3183
At Week 16
|
10616.79 nanograms per liter (ng/L)
Geometric Coefficient of Variation 78.77
|
11444.51 nanograms per liter (ng/L)
Geometric Coefficient of Variation 227.49
|
23327.81 nanograms per liter (ng/L)
Geometric Coefficient of Variation 72.11
|
9081.21 nanograms per liter (ng/L)
Geometric Coefficient of Variation 454.97
|
—
|
Adverse Events
ME3183 Dose 1, BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ME3183 Dose 2, QD
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
ME3183 Dose 3, BID
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ME3183 Dose 4, QD
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ME3183 Dose 1, BID
n=25 participants at risk
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 participants at risk
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 participants at risk
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 participants at risk
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 participants at risk
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
Other adverse events
| Measure |
ME3183 Dose 1, BID
n=25 participants at risk
Participants received ME3183 Dose 1 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 2, QD
n=26 participants at risk
Participants received ME3183 Dose 2 as a capsule along with matching placebo, once daily for 16 weeks.
|
ME3183 Dose 3, BID
n=26 participants at risk
Participants received ME3183 Dose 3 as a capsule along with matching placebo, twice daily for 16 weeks.
|
ME3183 Dose 4, QD
n=26 participants at risk
Participants received ME3183 Dose 4 as a capsule along with matching placebo, once daily for 16 weeks.
|
Placebo
n=27 participants at risk
Participants received matching placebo of ME3183 as a capsule, twice daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
34.6%
9/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
30.8%
8/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
38.5%
10/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.4%
2/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
30.8%
8/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.0%
3/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
15.4%
4/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.4%
2/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
11.5%
3/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.4%
2/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
42.3%
11/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
26.9%
7/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.4%
2/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Investigations
Lipase increased
|
4.0%
1/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
15.4%
4/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
11.5%
3/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
11.5%
3/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
15.4%
4/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
11.5%
3/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.8%
1/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
3.7%
1/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
General disorders
Fatigue
|
4.0%
1/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.7%
2/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
0.00%
0/26 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
7.4%
2/27 • From Baseline up to the end of the Follow-up Period (up to Week 20)
A TEAE is an AE that occurs during the study after the first dose of the study drug or that is present before dosing and exacerbates after the first dose of the study drug.
|
Additional Information
Meiji Pharma USA Inc. Study Lead
Meiji Pharma USA Inc.
Phone: +1 201-777-7133
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER