Trial Outcomes & Findings for AGN-242428 in the Treatment of Plaque Psoriasis (NCT NCT03339999)
NCT ID: NCT03339999
Last Updated: 2021-04-06
Results Overview
The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline (Day 1) to Week 16
Results posted on
2021-04-06
Participant Flow
As the study was terminated, no participants completed the planned dosing schedule of 16 weeks.
Participant milestones
| Measure |
Placebo
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
5
|
|
Overall Study
Modified Intent-to-Treat Population
|
7
|
6
|
5
|
4
|
|
Overall Study
Safety Population: Received Treatment
|
7
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
6
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
6
|
3
|
4
|
3
|
Baseline Characteristics
AGN-242428 in the Treatment of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
n=5 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
n=4 Participants
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 16.87 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 11.00 • n=4 Participants
|
48.5 years
STANDARD_DEVIATION 12.43 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Psoriasis Area and Severity Index (PASI) Score at Baseline
|
18.20 score on a scale
STANDARD_DEVIATION 4.819 • n=5 Participants
|
14.37 score on a scale
STANDARD_DEVIATION 3.635 • n=7 Participants
|
18.78 score on a scale
STANDARD_DEVIATION 7.281 • n=5 Participants
|
15.98 score on a scale
STANDARD_DEVIATION 3.699 • n=4 Participants
|
16.88 score on a scale
STANDARD_DEVIATION 5.023 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 16Population: No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint.
The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 16Population: No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint.
The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear and 4=Severe.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 16Population: No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint.
The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear to 4=Severe.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 16Population: No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint.
The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 16Population: No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 primary timepoint.
The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dosePopulation: Safety population included all participants who received at least 1 administration of study treatment.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
n=4 Participants
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dosePopulation: Safety population included all participants who received at least 1 administration of study treatment.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
n=4 Participants
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Discontinuation
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dosePopulation: Safety population included all participants who received at least 1 administration of study treatment.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. The TEAEs related to the study drug, as assessed by Investigator are reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
n=6 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
n=4 Participants
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 VisitsPopulation: Pharmacokinetic (PK) population included all participants who received AGN-242428 and had available plasma concentration data at the given timepoint. No PK data was collected at Week 12 for participants who received AGN-242428 or Week 16 as the study was terminated.
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
n=4 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
n=3 Participants
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Plasma Concentration of AGN-242428
Week 4
|
1500 ng/mL
Standard Deviation 692
|
1060 ng/mL
Standard Deviation 449
|
488 ng/mL
Standard Deviation 125
|
—
|
|
Plasma Concentration of AGN-242428
Week 6
|
3720 ng/mL
Standard Deviation NA
Standard deviation was not calculated due to limited PK data.
|
1150 ng/mL
Standard Deviation 881
|
718 ng/mL
Standard Deviation NA
Standard deviation was not calculated due to limited PK data.
|
—
|
|
Plasma Concentration of AGN-242428
Week 8
|
1300 ng/mL
Standard Deviation NA
Standard deviation was not calculated due to limited PK data.
|
886 ng/mL
Standard Deviation 376
|
616 ng/mL
Standard Deviation NA
Standard deviation was not calculated due to limited PK data.
|
—
|
|
Plasma Concentration of AGN-242428
Week 10
|
—
|
483 ng/mL
Standard Deviation NA
Standard deviation was not calculated due to limited PK data.
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AGN-242428 Higher Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-242428 Medium Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AGN-242428 Lower Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Higher Dose
n=6 participants at risk
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Medium Dose
n=6 participants at risk
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
|
AGN-242428 Lower Dose
n=4 participants at risk
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
33.3%
2/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
25.0%
1/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Cellulitis
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Hordeolum
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
33.3%
2/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
25.0%
1/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
33.3%
2/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
25.0%
1/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
33.3%
2/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
25.0%
1/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
25.0%
1/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
16.7%
1/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
14.3%
1/7 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/6 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
0.00%
0/4 • First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER