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
Administered as 12 mg tablets.
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
* Clinical presentation compatible with 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.
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 within 3 months of screening or during the study, or biologics within 6 months of screening or during the study. * Clinical lab results outside the normal range.
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 |
|---|---|---|
| Relative Change From Baseline in SALT Scores 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 Achieving at Least a 90%, 75%, and 50% 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 From Baseline in SALT Scores 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). |
| Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Baseline, Weeks 8, 12 and 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 Weeks 8, 12 and 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 | Description |
|---|---|---|
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 28 weeks | An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were enrolled at 12 study centers in Canada and the United States from 24 May 2019 to 10 April 2020.
Pre-assignment details
94 participants were screened out of which 66 participants who experienced an episode of hair loss due to alopecia areata were enrolled and randomized to receive CTP-543 12 milligrams (mg) twice daily (BID) or CTP-543 24 mg once daily (QD).
Participants by arm
| Arm | Count |
|---|---|
| CTP-543 12 mg BID Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. | 34 |
| CTP-543 24 mg QD Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks. | 32 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal of Informed Consent due to an Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | CTP-543 12 mg BID | Total | CTP-543 24 mg QD |
|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 11.89 | 39.6 years STANDARD_DEVIATION 12.99 | 40.4 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 63 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 48 Participants | 23 Participants |
| Severity of Alopecia Tool (SALT) Score | 85.77 score on a scale STANDARD_DEVIATION 19.473 | 86.73 score on a scale STANDARD_DEVIATION 18.328 | 87.76 score on a scale STANDARD_DEVIATION 17.28 |
| Sex: Female, Male Female | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Male | 13 Participants | 22 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 28 / 34 | 24 / 32 |
| serious Total, serious adverse events | 0 / 34 | 1 / 32 |
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: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTP-543 12 mg BID | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | 58.44 percent change | Standard Deviation 34.747 |
| CTP-543 24 mg QD | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | 51.96 percent change | Standard Deviation 37.887 |
Secondary
Absolute Change From Baseline in SALT Scores 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: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CTP-543 12 mg BID | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 4 | 1.95 score on a scale | Standard Deviation 4.247 |
| CTP-543 12 mg BID | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 8 | 11.68 score on a scale | Standard Deviation 17.674 |
| CTP-543 12 mg BID | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 12 | 26.07 score on a scale | Standard Deviation 28.086 |
| CTP-543 12 mg BID | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 16 | 38.83 score on a scale | Standard Deviation 30.699 |
| CTP-543 12 mg BID | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 20 | 45.44 score on a scale | Standard Deviation 32.169 |
| CTP-543 12 mg BID | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 24 | 48.63 score on a scale | Standard Deviation 31.733 |
| CTP-543 24 mg QD | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 20 | 37.78 score on a scale | Standard Deviation 31.021 |
| CTP-543 24 mg QD | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 4 | 3.02 score on a scale | Standard Deviation 5.211 |
| CTP-543 24 mg QD | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 16 | 31.32 score on a scale | Standard Deviation 28.637 |
| CTP-543 24 mg QD | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 8 | 13.61 score on a scale | Standard Deviation 15.795 |
| CTP-543 24 mg QD | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 24 | 42.82 score on a scale | Standard Deviation 31.47 |
| CTP-543 24 mg QD | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Change from Baseline at Week 12 | 25.33 score on a scale | Standard Deviation 27.874 |
Secondary
Percentage of Participants Achieving at Least a 90%, 75%, and 50% 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: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 4 | 0.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 8 | 0.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 12 | 8.8 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 16 | 20.6 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 20 | 32.4 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 24 | 32.4 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 4 | 0.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 8 | 0.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 12 | 14.7 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 16 | 23.5 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 20 | 35.3 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 24 | 38.2 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 4 | 0.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 8 | 8.8 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 12 | 32.4 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 16 | 44.1 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 20 | 52.9 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 24 | 61.8 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 8 | 0.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 4 | 0.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 16 | 25.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 8 | 0.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 24 | 53.1 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 12 | 6.3 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 20 | 31.3 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 16 | 12.5 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 12 | 31.3 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 20 | 21.9 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 24 | 34.4 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 90% Reduction: Week 24 | 31.3 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 20 | 43.8 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 4 | 0.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 4 | 0.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 8 | 0.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 50% Reduction: Week 16 | 40.6 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | 75% Reduction: Week 12 | 18.8 percentage of participants |
Secondary
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
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 Weeks 8, 12 and 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, Weeks 8, 12 and 24
Population: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized, with data available for analysis. Number analyzed indicates the number of participants with available data for analysis at the specific timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Satisfied to Satisfied | 3.6 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Satisfied to Dissatisfied | 0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Dissatisfied to Satisfied | 39.3 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Dissatisfied to Dissatisfied | 57.1 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Satisfied to Satisfied | 6.5 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Satisfied to Dissatisfied | 0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Dissatisfied to Satisfied | 35.5 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Dissatisfied to Dissatisfied | 58.1 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Satisfied to Satisfied | 6.3 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Satisfied to Dissatisfied | 0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Dissatisfied to Satisfied | 68.8 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Dissatisfied to Dissatisfied | 25.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Dissatisfied to Satisfied | 70.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Satisfied to Satisfied | 0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Dissatisfied to Satisfied | 67.7 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Satisfied to Dissatisfied | 0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Satisfied to Dissatisfied | 0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Dissatisfied to Satisfied | 44.8 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Dissatisfied to Dissatisfied | 32.3 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 8: Dissatisfied to Dissatisfied | 55.2 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Dissatisfied to Dissatisfied | 30.0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Satisfied to Satisfied | 0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 24: Satisfied to Satisfied | 0 percentage of participants |
| CTP-543 24 mg QD | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Week 12: Satisfied to Dissatisfied | 0 percentage of participants |
Secondary
Relative Change From Baseline in SALT Scores 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: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CTP-543 12 mg BID | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 8 | 14.57 percent change | Standard Deviation 19.8 |
| CTP-543 12 mg BID | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 16 | 47.20 percent change | Standard Deviation 34.663 |
| CTP-543 12 mg BID | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 12 | 32.10 percent change | Standard Deviation 30.96 |
| CTP-543 12 mg BID | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 20 | 54.58 percent change | Standard Deviation 35.582 |
| CTP-543 12 mg BID | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 4 | 3.12 percent change | Standard Deviation 7.474 |
| CTP-543 24 mg QD | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 20 | 46.24 percent change | Standard Deviation 37.891 |
| CTP-543 24 mg QD | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 4 | 3.95 percent change | Standard Deviation 7.126 |
| CTP-543 24 mg QD | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 8 | 17.24 percent change | Standard Deviation 19.034 |
| CTP-543 24 mg QD | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 12 | 31.90 percent change | Standard Deviation 33.82 |
| CTP-543 24 mg QD | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Change from Baseline at Week 16 | 39.08 percent change | Standard Deviation 35.75 |
Other Pre-specified
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event.
Time frame: From first dose up to 28 weeks
Population: Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTP-543 12 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | 28 Participants |
| CTP-543 24 mg QD | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | 24 Participants |