Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (NCT NCT04797650)
NCT ID: NCT04797650
Last Updated: 2023-07-03
Results Overview
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
517 participants
Primary outcome timeframe
Week 24
Results posted on
2023-07-03
Participant Flow
Participants were enrolled at study centers in Canada, France, Germany, Hungary, Poland, Spain and the United States from 10 June 2021 to 29 June 2022.
671 participants were screened, out of which 517 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.
Participant milestones
| Measure |
Placebo
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
|
CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
130
|
258
|
129
|
|
Overall Study
Efficacy Population
|
127
|
249
|
127
|
|
Overall Study
Safety Population
|
130
|
256
|
129
|
|
Overall Study
COMPLETED
|
119
|
233
|
120
|
|
Overall Study
NOT COMPLETED
|
11
|
25
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
|
CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Overall Study
Reason Not Specified
|
5
|
12
|
5
|
|
Overall Study
Treatment Emergent or Worsening Adverse Event
|
1
|
7
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Baseline characteristics by cohort
| Measure |
Placebo
n=130 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=258 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=129 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
Total
n=517 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 12.49 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 12.30 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 12.90 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 12.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
349 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
424 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
100 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
412 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported
|
11 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
|
0.8 Percentage of participants
|
33.0 Percentage of participants
|
38.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Responders were defined as participants with responses of "satisfied" or "very satisfied".
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Week 12
|
4.9 Percentage of responders
|
43.2 Percentage of responders
|
41.0 Percentage of responders
|
|
Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Week 16
|
4.9 Percentage of responders
|
41.0 Percentage of responders
|
45.1 Percentage of responders
|
|
Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Week 20
|
1.7 Percentage of responders
|
40.1 Percentage of responders
|
52.5 Percentage of responders
|
|
Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Week 24
|
1.7 Percentage of responders
|
46.5 Percentage of responders
|
51.7 Percentage of responders
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, and 20Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Week 4
|
0 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Week 8
|
0.8 percentage of participants
|
2.9 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Week 12
|
0.8 percentage of participants
|
10.5 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Week 16
|
0.8 percentage of participants
|
20.2 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Week 20
|
0.8 percentage of participants
|
24.8 percentage of participants
|
28.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measures. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[post-baseline SALT score - baseline SALT score\]/baseline SALT score).
Outcome measures
| Measure |
Placebo
n=125 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=242 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=125 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Relative Change From Baseline at Week 16
|
0.9 percentage change
Standard Deviation 13.19
|
-34.3 percentage change
Standard Deviation 34.93
|
-39.9 percentage change
Standard Deviation 35.43
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Relative Change From Baseline at Week 20
|
0.4 percentage change
Standard Deviation 15.49
|
-38.9 percentage change
Standard Deviation 37.64
|
-47.7 percentage change
Standard Deviation 37.62
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Relative Change From Baseline at Week 24
|
1.6 percentage change
Standard Deviation 16.54
|
-44.6 percentage change
Standard Deviation 39.58
|
-52.7 percentage change
Standard Deviation 38.44
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Relative Change From Baseline at Week 4
|
0.4 percentage change
Standard Deviation 5.40
|
-2.6 percentage change
Standard Deviation 10.10
|
-3.2 percentage change
Standard Deviation 9.45
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Relative Change From Baseline at Week 8
|
-2.0 percentage change
Standard Deviation 13.41
|
-11.5 percentage change
Standard Deviation 20.63
|
-16.4 percentage change
Standard Deviation 23.92
|
|
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Relative Change From Baseline at Week 12
|
-0.7 percentage change
Standard Deviation 14.72
|
-23.9 percentage change
Standard Deviation 29.06
|
-30.3 percentage change
Standard Deviation 31.85
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Week 12
|
3.3 Percentage of responders
|
38.0 Percentage of responders
|
44.3 Percentage of responders
|
|
Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Week 16
|
3.2 Percentage of responders
|
45.0 Percentage of responders
|
52.0 Percentage of responders
|
|
Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Week 20
|
1.7 Percentage of responders
|
50.0 Percentage of responders
|
59.0 Percentage of responders
|
|
Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Week 24
|
2.5 Percentage of responders
|
54.1 Percentage of responders
|
61.7 Percentage of responders
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Week 12
|
3.3 Percentage of responders
|
43.3 Percentage of responders
|
49.2 Percentage of responders
|
|
Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Week 16
|
4.0 Percentage of responders
|
46.2 Percentage of responders
|
59.8 Percentage of responders
|
|
Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Week 20
|
5.8 Percentage of responders
|
48.7 Percentage of responders
|
64.4 Percentage of responders
|
|
Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Week 24
|
1.7 Percentage of responders
|
50.9 Percentage of responders
|
68.3 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Outcome measures
| Measure |
Placebo
n=123 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=236 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=124 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Baseline
|
6.4 Score on a scale
Standard Deviation 0.82
|
6.5 Score on a scale
Standard Deviation 0.83
|
6.4 Score on a scale
Standard Deviation 0.76
|
|
Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 12
|
0.0 Score on a scale
Standard Deviation 0.75
|
-1.3 Score on a scale
Standard Deviation 1.45
|
-1.5 Score on a scale
Standard Deviation 1.52
|
|
Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 16
|
0.1 Score on a scale
Standard Deviation 0.67
|
-1.6 Score on a scale
Standard Deviation 1.61
|
-1.8 Score on a scale
Standard Deviation 1.69
|
|
Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 20
|
-0.0 Score on a scale
Standard Deviation 0.96
|
-1.8 Score on a scale
Standard Deviation 1.80
|
-2.2 Score on a scale
Standard Deviation 1.83
|
|
Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 24
|
0.1 Score on a scale
Standard Deviation 0.79
|
-2.1 Score on a scale
Standard Deviation 1.97
|
-2.4 Score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1= normal, no hair loss; 2= borderline hair loss; 3= mild hair loss; 4= moderate hair loss; 5= marked hair loss; 6= severe hair loss; 7= among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Outcome measures
| Measure |
Placebo
n=124 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=236 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=124 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Baseline
|
6.7 Score on a scale
Standard Deviation 0.64
|
6.6 Score on a scale
Standard Deviation 0.79
|
6.5 Score on a scale
Standard Deviation 0.78
|
|
Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 12
|
-0.2 Score on a scale
Standard Deviation 0.97
|
-1.6 Score on a scale
Standard Deviation 2.05
|
-1.8 Score on a scale
Standard Deviation 1.88
|
|
Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 16
|
-0.2 Score on a scale
Standard Deviation 1.06
|
-1.8 Score on a scale
Standard Deviation 2.10
|
-2.0 Score on a scale
Standard Deviation 1.90
|
|
Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 20
|
-0.3 Score on a scale
Standard Deviation 1.26
|
-2.0 Score on a scale
Standard Deviation 2.20
|
-2.2 Score on a scale
Standard Deviation 1.91
|
|
Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 24
|
-0.2 Score on a scale
Standard Deviation 1.04
|
-2.3 Score on a scale
Standard Deviation 2.26
|
-2.5 Score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
75% Relative Reduction: Week 12
|
0 Percentage of participants
|
8.9 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
75% Relative Reduction: Week 24
|
0 Percentage of participants
|
33.5 Percentage of participants
|
38.3 Percentage of participants
|
|
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
90% Relative Reduction: Week 12
|
0 Percentage of participants
|
1.7 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
90% Relative Reduction: Week 24
|
0 Percentage of participants
|
21.9 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0= no eyebrow, 1= minimal eyebrow, 2= moderate eyebrow, and 3= normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.
Outcome measures
| Measure |
Placebo
n=95 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=173 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=90 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Baseline
|
0.9 Score on a scale
Standard Deviation 1.64
|
0.7 Score on a scale
Standard Deviation 1.44
|
1.1 Score on a scale
Standard Deviation 1.65
|
|
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Change From Baseline at Week 12
|
-0.3 Score on a scale
Standard Deviation 0.93
|
0.8 Score on a scale
Standard Deviation 1.53
|
0.7 Score on a scale
Standard Deviation 1.66
|
|
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Change From Baseline at Week 24
|
-0.3 Score on a scale
Standard Deviation 1.1
|
1.2 Score on a scale
Standard Deviation 1.76
|
1.2 Score on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=165 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=82 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
Baseline
|
0.7 Score on a scale
Standard Deviation 1.38
|
0.9 Score on a scale
Standard Deviation 1.68
|
1.1 Score on a scale
Standard Deviation 1.83
|
|
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
Change From Baseline at Week 12
|
-0.1 Score on a scale
Standard Deviation 0.91
|
0.9 Score on a scale
Standard Deviation 1.60
|
1.0 Score on a scale
Standard Deviation 1.76
|
|
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
Change From Baseline at Week 24
|
-0.0 Score on a scale
Standard Deviation 0.93
|
1.4 Score on a scale
Standard Deviation 2.09
|
1.3 Score on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 20 and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.
Outcome measures
| Measure |
Placebo
n=124 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=236 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=124 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Baseline
|
4.5 Score on a scale
Standard Deviation 0.85
|
4.6 Score on a scale
Standard Deviation 0.71
|
4.6 Score on a scale
Standard Deviation 0.80
|
|
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 12
|
-0.4 Score on a scale
Standard Deviation 1.14
|
-1.6 Score on a scale
Standard Deviation 1.39
|
-1.7 Score on a scale
Standard Deviation 1.33
|
|
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 16
|
-0.1 Score on a scale
Standard Deviation 1.10
|
-1.6 Score on a scale
Standard Deviation 1.31
|
-1.7 Score on a scale
Standard Deviation 1.36
|
|
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 20
|
-0.1 Score on a scale
Standard Deviation 0.97
|
-1.5 Score on a scale
Standard Deviation 1.40
|
-1.9 Score on a scale
Standard Deviation 1.38
|
|
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Change From Baseline at Week 24
|
-0.1 Score on a scale
Standard Deviation 0.93
|
-1.6 Score on a scale
Standard Deviation 1.47
|
-1.9 Score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
SPRO is a questionnaire answered by the participants and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Week 12
|
15.6 Percentage of participants
|
50.4 Percentage of participants
|
59.0 Percentage of participants
|
|
Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Week 16
|
9.8 Percentage of participants
|
52.6 Percentage of participants
|
57.4 Percentage of participants
|
|
Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Week 20
|
9.2 Percentage of participants
|
50.4 Percentage of participants
|
63.6 Percentage of participants
|
|
Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Week 24
|
8.5 Percentage of participants
|
52.6 Percentage of participants
|
61.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 20, and 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Outcome measures
| Measure |
Placebo
n=124 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=236 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=124 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied Thickness Hair Coverage: Change From Baseline at Week 12
|
-0.3 Score on a scale
Standard Deviation 0.95
|
-1.3 Score on a scale
Standard Deviation 1.20
|
-1.4 Score on a scale
Standard Deviation 1.35
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied Thickness Hair Coverage: Baseline
|
4.6 Score on a scale
Standard Deviation 0.76
|
4.6 Score on a scale
Standard Deviation 0.66
|
4.6 Score on a scale
Standard Deviation 0.83
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied Thickness Hair Coverage: Change From Baseline at Week 16
|
-0.1 Score on a scale
Standard Deviation 0.91
|
-1.3 Score on a scale
Standard Deviation 1.23
|
-1.5 Score on a scale
Standard Deviation 1.30
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied Thickness Hair Coverage: Change From Baseline at Week 20
|
-0.1 Score on a scale
Standard Deviation 0.85
|
-1.3 Score on a scale
Standard Deviation 1.35
|
-1.7 Score on a scale
Standard Deviation 1.36
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied Thickness Hair Coverage: Change From Baseline at Week 24
|
-0.1 Score on a scale
Standard Deviation 0.89
|
-1.4 Score on a scale
Standard Deviation 1.46
|
-1.6 Score on a scale
Standard Deviation 1.41
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied evenness hair coverage: Baseline
|
4.7 Score on a scale
Standard Deviation 0.61
|
4.7 Score on a scale
Standard Deviation 0.58
|
4.7 Score on a scale
Standard Deviation 0.74
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied evenness hair coverage: Change From Baseline at Week 12
|
-0.3 Score on a scale
Standard Deviation 0.78
|
-1.2 Score on a scale
Standard Deviation 1.10
|
-1.3 Score on a scale
Standard Deviation 1.26
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied evenness hair coverage: Change From Baseline at Week 16
|
-0.2 Score on a scale
Standard Deviation 0.82
|
-1.1 Score on a scale
Standard Deviation 1.12
|
-1.3 Score on a scale
Standard Deviation 1.20
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied evenness hair coverage: Change From Baseline at Week 20
|
-0.1 Score on a scale
Standard Deviation 0.76
|
-1.3 Score on a scale
Standard Deviation 1.27
|
-1.5 Score on a scale
Standard Deviation 1.29
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Satisfied evenness hair coverage: Change From Baseline at Week 24
|
-0.1 Score on a scale
Standard Deviation 0.71
|
-1.4 Score on a scale
Standard Deviation 1.36
|
-1.6 Score on a scale
Standard Deviation 1.37
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyebrows: Baseline
|
4.3 Score on a scale
Standard Deviation 1.07
|
4.3 Score on a scale
Standard Deviation 1.16
|
4.1 Score on a scale
Standard Deviation 1.32
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyebrows: Change From Baseline at Week 12
|
-0.2 Score on a scale
Standard Deviation 0.84
|
-1.3 Score on a scale
Standard Deviation 1.31
|
-1.3 Score on a scale
Standard Deviation 1.42
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyebrows: Change From Baseline at Week 16
|
-0.2 Score on a scale
Standard Deviation 0.78
|
-1.2 Score on a scale
Standard Deviation 1.28
|
-1.4 Score on a scale
Standard Deviation 1.54
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyebrows: Change From Baseline at Week 20
|
-0.1 Score on a scale
Standard Deviation 0.78
|
-1.4 Score on a scale
Standard Deviation 1.40
|
-1.4 Score on a scale
Standard Deviation 1.47
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyebrows: Change From Baseline at Week 24
|
-0.1 Score on a scale
Standard Deviation 0.81
|
-1.4 Score on a scale
Standard Deviation 1.43
|
-1.6 Score on a scale
Standard Deviation 1.50
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyelashes: Baseline
|
4.1 Score on a scale
Standard Deviation 1.23
|
4.1 Score on a scale
Standard Deviation 1.32
|
3.8 Score on a scale
Standard Deviation 1.42
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyelashes: Change From Baseline at Week 12
|
-0.2 Score on a scale
Standard Deviation 0.72
|
-1.1 Score on a scale
Standard Deviation 1.34
|
-1.0 Score on a scale
Standard Deviation 1.29
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyelashes: Change From Baseline at Week 16
|
-0.2 Score on a scale
Standard Deviation 0.82
|
-1.1 Score on a scale
Standard Deviation 1.29
|
-1.1 Score on a scale
Standard Deviation 1.41
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyelashes: Change From Baseline at Week 20
|
-0.1 Score on a scale
Standard Deviation 0.83
|
-1.2 Score on a scale
Standard Deviation 1.39
|
-1.2 Score on a scale
Standard Deviation 1.31
|
|
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
How satisfied with your eyelashes: Change From Baseline at Week 24
|
-0.1 Score on a scale
Standard Deviation 0.73
|
-1.3 Score on a scale
Standard Deviation 1.41
|
-1.3 Score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy population= included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the= number of participants with data available for analysis of this outcome measure. Number of participants analyzed= indicates the number of participants with data available for analysis at the specified timepoint.
HADS is questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Outcome measures
| Measure |
Placebo
n=118 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=228 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=120 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Anxiety: Baseline
|
6.2 Score on a scale
Standard Deviation 3.99
|
6.4 Score on a scale
Standard Deviation 4.21
|
6.2 Score on a scale
Standard Deviation 3.79
|
|
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Anxiety: Change From Baseline at Week 24
|
-0.6 Score on a scale
Standard Deviation 2.74
|
-1.1 Score on a scale
Standard Deviation 3.00
|
-0.8 Score on a scale
Standard Deviation 2.85
|
|
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Depression: Baseline
|
4.7 Score on a scale
Standard Deviation 3.96
|
4.2 Score on a scale
Standard Deviation 3.66
|
4.3 Score on a scale
Standard Deviation 3.56
|
|
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Depression: Change From Baseline at Week 24
|
-0.6 Score on a scale
Standard Deviation 2.97
|
-1.2 Score on a scale
Standard Deviation 3.16
|
-1.5 Score on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Week 24Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=249 Participants
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=127 Participants
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24
|
0 Percentage of participants
|
24.9 Percentage of participants
|
26.7 Percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
CTP-543 8 mg BID
Serious events: 3 serious events
Other events: 137 other events
Deaths: 0 deaths
CTP-543 12 mg BID
Serious events: 2 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=130 participants at risk
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=256 participants at risk
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=129 participants at risk
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.00%
0/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.78%
1/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.39%
1/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.00%
0/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.00%
0/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.78%
1/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.39%
1/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.00%
0/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.39%
1/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
0.00%
0/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
Other adverse events
| Measure |
Placebo
n=130 participants at risk
Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.
|
CTP-543 8 mg BID
n=256 participants at risk
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
|
CTP-543 12 mg BID
n=129 participants at risk
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
16.9%
22/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
23.4%
60/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
18.6%
24/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Infections and infestations
Asymptomatic COVID-19
|
16.9%
22/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
12.9%
33/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
16.3%
21/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
12.3%
16/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
12.9%
33/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
12.4%
16/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Nervous system disorders
Headache
|
14.6%
19/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
12.5%
32/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
10.1%
13/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.3%
3/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
9.0%
23/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
10.1%
13/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
4/130 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
5.1%
13/256 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
11.6%
15/129 • All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
|
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