Alopecia Areata
Conditions
Brief summary
This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
Interventions
DRUGCTP-543
CTP-543 administered as 8 mg tablet.
Administered as tablets to aid treatment masking.
Sponsors
Concert Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted. * At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline. * Clinical lab results within the normal range
Exclusion criteria
* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp. * Treatment with systemic immunosuppressive medications or biologics. * Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline, Week 24 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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). |
| Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Baseline, Weeks 4, 8, 12, 16 and 20 | 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). |
| Percentage of Participants With Change in Satisfaction of Hair Coverage | Baseline, Week 24 | 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. |
Other
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 24 Weeks |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 10 study centers in the United States from 21 March 2019 to 21 November 2019.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 28 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrew Consent | 4 | 2 |
Baseline characteristics
| Characteristic | CTP-543 8 mg BID | Total | CTP-543 16 mg QD |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 12.98 | 40.1 years STANDARD_DEVIATION 13.2 | 39.8 years STANDARD_DEVIATION 13.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 50 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 27 Participants | 50 Participants | 23 Participants |
| Region of Enrollment United States | 29 participants | 57 participants | 28 participants |
| Severity of Alopecia Tool (SALT) Score | 87.1 score on a scale STANDARD_DEVIATION 17.23 | 88.7 score on a scale STANDARD_DEVIATION 17.27 | 90.4 score on a scale STANDARD_DEVIATION 17.46 |
| Sex: Female, Male Female | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 23 / 29 | 23 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
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).
Time frame: Baseline, Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTP-543 8 mg BID | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | 46.4 percent change | Standard Deviation 38.21 |
| CTP-543 16 mg QD | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | 18.0 percent change | Standard Deviation 32.32 |
Secondary
Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
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).
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 16 mg QD | Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 20 | 13.4 Score on a scale | Standard Deviation 28.06 |
| CTP-543 16 mg QD | 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 4.49 |
| CTP-543 16 mg QD | Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 16 | 9.4 Score on a scale | Standard Deviation 25.46 |
| CTP-543 16 mg QD | Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 8 | 2.1 Score on a scale | Standard Deviation 11.93 |
| CTP-543 16 mg QD | Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 24 | 15.7 Score on a scale | Standard Deviation 28.25 |
| CTP-543 16 mg QD | Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 12 | 5.3 Score on a scale | Standard Deviation 19.48 |
Secondary
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 50% Reduction: Week 8 | 3.6 Percentage of participants |
| CTP-543 16 mg QD | 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 |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 75% Reduction: Week 16 | 3.6 Percentage of participants |
| CTP-543 16 mg QD | 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 |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 50% Reduction: Week 24 | 17.9 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 90% Reduction: Week 12 | 0 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 75% Reduction: Week 20 | 10.7 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 90% Reduction: Week 16 | 0 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 50% Reduction: Week 12 | 7.1 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 90% Reduction: Week 20 | 0 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 75% Reduction: Week 24 | 10.7 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 90% Reduction: Week 24 | 3.6 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 50% Reduction: Week 20 | 14.3 Percentage of participants |
| CTP-543 16 mg QD | 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 |
| CTP-543 16 mg QD | 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 |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 75% Reduction: Week 8 | 3.6 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 50% Reduction: Week 16 | 14.3 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | 75% Reduction: Week 12 | 0 Percentage of participants |
Secondary
Percentage of Participants With Change in Satisfaction of Hair Coverage
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.
Time frame: Baseline, Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP-543 8 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage | Satisfied to Satisfied | 0 Percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage | Satisfied to Dissatisfied | 3.4 Percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage | Dissatisfied to Satisfied | 55.2 Percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage | Dissatisfied to Dissatisfied | 34.5 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage | Dissatisfied to Dissatisfied | 75.0 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage | Satisfied to Satisfied | 3.6 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage | Dissatisfied to Satisfied | 17.9 Percentage of participants |
| CTP-543 16 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage | Satisfied to Dissatisfied | 0 Percentage of participants |
Secondary
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20
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).
Time frame: Baseline, Weeks 4, 8, 12, 16 and 20
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 35.9 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 8 mg BID | 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 |
| CTP-543 16 mg QD | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 20 | 14.8 percent change | Standard Deviation 31.26 |
| CTP-543 16 mg QD | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 4 | -1.3 percent change | Standard Deviation 7.26 |
| CTP-543 16 mg QD | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 8 | 2.7 percent change | Standard Deviation 19.43 |
| CTP-543 16 mg QD | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 12 | 5.1 percent change | Standard Deviation 22.91 |
| CTP-543 16 mg QD | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 16 | 9.4 percent change | Standard Deviation 28.85 |
Other Pre-specified
Number of Participants With Adverse Events as a Measure of Safety
Time frame: 24 Weeks