Trial Outcomes & Findings for Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata (NCT NCT03811912)
NCT ID: NCT03811912
Last Updated: 2022-12-09
Results Overview
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2022-12-09
Participant Flow
Participants were enrolled at 10 study centers in the United States from 21 March 2019 to 21 November 2019.
70 participants were screened out of which 57 participants who experienced an episode of hair loss due to alopecia areata were enrolled and randomized to receive CTP-543 8 mg twice daily (BID) or CTP-543 16 mg once daily (QD).
Participant milestones
| Measure |
CTP-543 8 mg BID
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
Safety Population
|
29
|
28
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
CTP-543 8 mg BID
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
4
|
2
|
Baseline Characteristics
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Baseline characteristics by cohort
| Measure |
CTP-543 8 mg BID
n=29 Participants
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 Participants
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 12.98 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 13.65 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Severity of Alopecia Tool (SALT) Score
|
87.1 score on a scale
STANDARD_DEVIATION 17.23 • n=5 Participants
|
90.4 score on a scale
STANDARD_DEVIATION 17.46 • n=7 Participants
|
88.7 score on a scale
STANDARD_DEVIATION 17.27 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
Outcome measures
| Measure |
CTP-543 8 mg BID
n=29 Participants
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 Participants
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
|
46.4 percent change
Standard Deviation 38.21
|
18.0 percent change
Standard Deviation 32.32
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.
Outcome measures
| Measure |
CTP-543 8 mg BID
n=29 Participants
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 Participants
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
90% Reduction: Week 4
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
90% Reduction: Week 8
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
90% Reduction: Week 12
|
3.4 Percentage of participants
Interval 0.0 to 10.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
90% Reduction: Week 16
|
6.9 Percentage of participants
Interval 0.0 to 16.4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
90% Reduction: Week 20
|
13.8 Percentage of participants
Interval 1.5 to 26.0
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
90% Reduction: Week 24
|
20.7 Percentage of participants
Interval 6.6 to 34.8
|
3.6 Percentage of participants
Interval 0.0 to 11.1
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
75% Reduction: Week 4
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
75% Reduction: Week 8
|
3.4 Percentage of participants
Interval 0.0 to 10.7
|
3.6 Percentage of participants
Interval 0.0 to 11.1
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
75% Reduction: Week 12
|
6.9 Percentage of participants
Interval 0.0 to 16.4
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
75% Reduction: Week 16
|
20.7 Percentage of participants
Interval 6.6 to 34.8
|
3.6 Percentage of participants
Interval 0.0 to 11.1
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
75% Reduction: Week 20
|
31.0 Percentage of participants
Interval 15.2 to 46.9
|
10.7 Percentage of participants
Interval 0.0 to 22.1
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
75% Reduction: Week 24
|
31.0 Percentage of participants
Interval 15.2 to 46.9
|
10.7 Percentage of participants
Interval 0.0 to 22.1
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
50% Reduction: Week 4
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
50% Reduction: Week 8
|
6.9 Percentage of participants
Interval 0.0 to 16.4
|
3.6 Percentage of participants
Interval 0.0 to 11.1
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
50% Reduction: Week 12
|
24.1 Percentage of participants
Interval 9.3 to 38.9
|
7.1 Percentage of participants
Interval 0.0 to 16.9
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
50% Reduction: Week 16
|
34.5 Percentage of participants
Interval 18.2 to 50.7
|
14.3 Percentage of participants
Interval 1.6 to 26.9
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
50% Reduction: Week 20
|
41.4 Percentage of participants
Interval 24.6 to 58.1
|
14.3 Percentage of participants
Interval 1.6 to 26.9
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
50% Reduction: Week 24
|
48.3 Percentage of participants
Interval 31.3 to 65.3
|
17.9 Percentage of participants
Interval 4.2 to 31.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).
Outcome measures
| Measure |
CTP-543 8 mg BID
n=29 Participants
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 Participants
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 4
|
0.8 Score on a scale
Standard Deviation 6.92
|
-0.8 Score on a scale
Standard Deviation 4.49
|
|
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 8
|
6.5 Score on a scale
Standard Deviation 15.02
|
2.1 Score on a scale
Standard Deviation 11.93
|
|
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 12
|
18.5 Score on a scale
Standard Deviation 23.27
|
5.3 Score on a scale
Standard Deviation 19.48
|
|
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 16
|
27.0 Score on a scale
Standard Deviation 29.31
|
9.4 Score on a scale
Standard Deviation 25.46
|
|
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 20
|
32.8 Score on a scale
Standard Deviation 29.25
|
13.4 Score on a scale
Standard Deviation 28.06
|
|
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 24
|
37.7 Score on a scale
Standard Deviation 30.75
|
15.7 Score on a scale
Standard Deviation 28.25
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16 and 20Population: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
Outcome measures
| Measure |
CTP-543 8 mg BID
n=29 Participants
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 Participants
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 8
|
8.6 percent change
Standard Deviation 20.58
|
2.7 percent change
Standard Deviation 19.43
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 4
|
1.4 percent change
Standard Deviation 9.67
|
-1.3 percent change
Standard Deviation 7.26
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 12
|
23.7 percent change
Standard Deviation 31.25
|
5.1 percent change
Standard Deviation 22.91
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 16
|
33.3 percent change
Standard Deviation 35.90
|
9.4 percent change
Standard Deviation 28.85
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 20
|
40.6 percent change
Standard Deviation 36.85
|
14.8 percent change
Standard Deviation 31.26
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen.
Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to the Week 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.
Outcome measures
| Measure |
CTP-543 8 mg BID
n=29 Participants
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 Participants
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage
Satisfied to Satisfied
|
0 Percentage of participants
|
3.6 Percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage
Satisfied to Dissatisfied
|
3.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage
Dissatisfied to Satisfied
|
55.2 Percentage of participants
|
17.9 Percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage
Dissatisfied to Dissatisfied
|
34.5 Percentage of participants
|
75.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksOutcome measures
Outcome data not reported
Adverse Events
CTP-543 8 mg BID
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
CTP-543 16 mg QD
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CTP-543 8 mg BID
n=29 participants at risk
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 16 mg QD
n=28 participants at risk
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.2%
5/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
17.9%
5/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.2%
5/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.7%
3/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
3/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
3.6%
1/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
13.8%
4/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
14.3%
4/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.1%
2/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.1%
2/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Nervous system disorders
Headache
|
27.6%
8/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
17.9%
5/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.1%
2/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Weight increased
|
3.4%
1/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.7%
3/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
3.6%
1/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/29 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.1%
2/28 • Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
- Publication restrictions are in place
Restriction type: OTHER