Alopecia Areata
Conditions
Keywords
CTP-543
Brief summary
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.
Interventions
DRUGCTP-543
Oral dosing
DRUGPlacebo
Oral dosing
Sponsors
Concert Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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. * Willing to comply with the study visits and requirements of the study protocol.
Exclusion criteria
* Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response. * Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline. * 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. * Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug. * Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction | From Week 24 to Week 48 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant. |
| Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | From Week 24 to Week 48 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant. |
| Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | Week 24 of re-treatment | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Weeks 28, 32, 36, 40, 44, and 48 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. |
| Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Weeks 12, 16, 20, and 24 | 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. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'. |
| Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Weeks 4, 8, 12, 16, 20, and 24 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). |
| Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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). Negative change indicates no hair loss. |
| Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Weeks 12, 16, 20, and 24 | 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). |
| Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Weeks 12, 16, 20, and 24 | 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). PGI responder is a response of 'very much improved' or 'much improved'. |
| Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline, Weeks 12, 16, 20, and 24 | 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. |
| Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | Baseline, Weeks 12, 16, 20, and 24 | 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 indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality. |
| Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment | 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). |
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to last follow up visit (Week 76) | 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. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs. |
| Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline, Weeks 12, 16, 20, and 24 | 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. |
| Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Weeks 4, 8, 12, 16, 20, and 24 of re-treatment | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment. |
| Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Weeks 28, 32, 36, 40, 44, and 48 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study centers in the United States from 26 February 2021 to 16 May 2023.
Pre-assignment details
429 participants were screened, out of which 317 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Part A: Period 1 - CTP-543 8 mg BID Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | 180 |
| Part A: Period 1 - CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. | 137 |
| Total | 317 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Period 1 (Day 1 to Week 24) | Lack of Efficacy | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Period 1 (Day 1 to Week 24) | Lost to Follow-up | 5 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Period 1 (Day 1 to Week 24) | Non-compliance With Study Drug | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Period 1 (Day 1 to Week 24) | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Period 1 (Day 1 to Week 24) | Reason not Specified | 5 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Period 1 (Day 1 to Week 24) | Treatment Emergent or Worsening Adverse Event | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Period 2 (Week 24 to Week 48) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B (Day 1 to Week 24) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part B (Day 1 to Week 24) | Reason not Specified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Part A: Period 1 - CTP-543 8 mg BID | Part A: Period 1 - CTP-543 12 mg BID | Total |
|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 14.05 | 39.6 years STANDARD_DEVIATION 13.21 | 39.8 years STANDARD_DEVIATION 13.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 11 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 167 Participants | 126 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 14 Participants | 9 Participants | 23 Participants |
| Race/Ethnicity, Customized Race Black or African American | 41 Participants | 24 Participants | 65 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 121 Participants | 102 Participants | 223 Participants |
| Sex: Female, Male Female | 119 Participants | 93 Participants | 212 Participants |
| Sex: Female, Male Male | 61 Participants | 44 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 137 | 0 / 18 | 0 / 25 | 0 / 18 | 0 / 25 | 0 / 5 | 0 / 8 | 0 / 15 | 0 / 19 |
| other Total, other adverse events | 91 / 180 | 82 / 137 | 9 / 18 | 10 / 25 | 7 / 18 | 9 / 25 | 2 / 5 | 5 / 8 | 12 / 15 | 14 / 19 |
| serious Total, serious adverse events | 1 / 180 | 5 / 137 | 0 / 18 | 0 / 25 | 2 / 18 | 0 / 25 | 0 / 5 | 0 / 8 | 0 / 15 | 0 / 19 |
Outcome results
Primary
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Time frame: From Week 24 to Week 48
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | 83.3 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | 80.0 Percentage of participants |
Primary
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Time frame: From Week 24 to Week 48
Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction | 27.8 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction | 32.0 Percentage of participants |
Primary
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.
Time frame: Week 24 of re-treatment
Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | 60.0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | 50.0 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | 66.7 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | 73.7 Percentage of participants |
Secondary
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
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. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs.
Time frame: From first dose of study drug up to last follow up visit (Week 76)
Population: Safety population included all participants who received study drug during the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 124 Participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 100 Participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 9 Participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 12 Participants |
| Part A: Period 2 - CTP-543 8 mg BID to Placebo | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 7 Participants |
| Part A: Period 2 - CTP-543 12 mg BID to Placebo | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 11 Participants |
| Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 2 Participants |
| Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 5 Participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 12 Participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs) | 14 Participants |
Secondary
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
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.
Time frame: Baseline, Weeks 12, 16, 20, and 24
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.8 Score on a scale | Standard Deviation 1.15 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.3 Score on a scale | Standard Deviation 1.38 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.37 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.6 Score on a scale | Standard Deviation 1.64 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 0.78 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -2.4 Score on a scale | Standard Deviation 1.92 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 6.3 Score on a scale | Standard Deviation 0.95 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.4 Score on a scale | Standard Deviation 1.63 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.8 Score on a scale | Standard Deviation 1.74 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -2.1 Score on a scale | Standard Deviation 1.84 |
Comparison: Week 1295% CI: [-0.9, -0.3]
Comparison: Week 1695% CI: [-1.1, -0.4]
Comparison: Week 2095% CI: [-1.2, -0.4]
Comparison: Week 2495% CI: [-1.2, -0.3]
Secondary
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
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 indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Time frame: Baseline, Weeks 12, 16, 20, and 24
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.8 Score on a scale | Standard Deviation 1.2 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.0 Score on a scale | Standard Deviation 1.17 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.23 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.0 Score on a scale | Standard Deviation 1.28 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.29 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.8 Score on a scale | Standard Deviation 1.09 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | 3.7 Score on a scale | Standard Deviation 1.4 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.0 Score on a scale | Standard Deviation 1.15 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.7 Score on a scale | Standard Deviation 1.12 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.8 Score on a scale | Standard Deviation 1.25 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.9 Score on a scale | Standard Deviation 1.07 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.8 Score on a scale | Standard Deviation 1.22 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.9 Score on a scale | Standard Deviation 1.28 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.2 Score on a scale | Standard Deviation 1.38 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 0.74 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.0 Score on a scale | Standard Deviation 1.11 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.9 Score on a scale | Standard Deviation 1.17 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.22 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | 4.0 Score on a scale | Standard Deviation 1.23 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 0.62 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.4 Score on a scale | Standard Deviation 1.37 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.3 Score on a scale | Standard Deviation 1.15 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.5 Score on a scale | Standard Deviation 1.14 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.7 Score on a scale | Standard Deviation 1.16 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.7 Score on a scale | Standard Deviation 1.25 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 0.64 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.3 Score on a scale | Standard Deviation 1.09 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.4 Score on a scale | Standard Deviation 1.14 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.6 Score on a scale | Standard Deviation 1.19 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | 4.1 Score on a scale | Standard Deviation 1.35 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.4 Score on a scale | Standard Deviation 1.44 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.7 Score on a scale | Standard Deviation 1.42 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | 3.7 Score on a scale | Standard Deviation 1.44 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.3 Score on a scale | Standard Deviation 1.42 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.5 Score on a scale | Standard Deviation 1.41 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.7 Score on a scale | Standard Deviation 1.18 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.4 Score on a scale | Standard Deviation 1.43 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.5 Score on a scale | Standard Deviation 1.32 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.42 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 0.67 |
Comparison: Satisfied Thickness Hair Coverage: Week 1295% CI: [-0.7, -0.2]
Comparison: Satisfied Thickness Hair Coverage: Week 1695% CI: [-0.7, -0.2]
Comparison: Satisfied Thickness Hair Coverage: Week 2095% CI: [-0.8, -0.3]
Comparison: Satisfied Thickness Hair Coverage: Week 2495% CI: [-0.8, -0.2]
Comparison: Satisfied Evenness Hair Coverage: Week 1295% CI: [-0.8, -0.3]
Comparison: Satisfied Evenness Hair Coverage: Week 1695% CI: [-0.7, -0.3]
Comparison: Satisfied Evenness Hair Coverage: Week 2095% CI: [-0.8, -0.3]
Comparison: Satisfied Evenness Hair Coverage: Week 2495% CI: [-0.8, -0.3]
Comparison: How Satisfied With Your Eyebrows: Week 1295% CI: [-0.8, -0.2]
Comparison: How Satisfied With Your Eyebrows: Week 1695% CI: [-0.6, -0.1]
Comparison: How Satisfied With Your Eyebrows: Week 2095% CI: [-0.7, -0.1]
Comparison: How Satisfied With Your Eyebrows: Week 2495% CI: [-0.7, -0.2]
Comparison: How Satisfied With Your Eyelashes: Week 1295% CI: [-0.7, -0.2]
Comparison: How Satisfied With Your Eyelashes: Week 1695% CI: [-0.7, -0.2]
Comparison: How Satisfied With Your Eyelashes: Week 2095% CI: [-0.7, -0.2]
Comparison: How Satisfied With Your Eyelashes: Week 2495% CI: [-0.8, -0.3]
Secondary
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
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.
Time frame: Baseline, Weeks 12, 16, 20, and 24
Population: The Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 6.4 Score on a scale | Standard Deviation 0.75 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -0.8 Score on a scale | Standard Deviation 1.31 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.0 Score on a scale | Standard Deviation 1.41 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.41 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: 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 | -1.4 Score on a scale | Standard Deviation 1.66 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -2.3 Score on a scale | Standard Deviation 1.95 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 6.4 Score on a scale | Standard Deviation 0.84 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -2.1 Score on a scale | Standard Deviation 1.78 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.1 Score on a scale | Standard Deviation 1.56 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: 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 | -1.6 Score on a scale | Standard Deviation 1.74 |
Comparison: Week 1295% CI: [-0.7, -0.1]
Comparison: Week 1695% CI: [-1, -0.3]
Comparison: Week 2095% CI: [-1.2, -0.5]
Comparison: Week 2495% CI: [-1.2, -0.4]
Secondary
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 4 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 8 | 1.7 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 12 | 5.8 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 16 | 10.2 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 20 | 15.9 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 24 | 22.1 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 20 | 35.2 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 4 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 16 | 24.2 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 8 | 2.3 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 24 | 42.9 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Week 12 | 16.4 Percentage of participants |
Comparison: Week 895% CI: [-2.7, 3.9]
Comparison: Week 1295% CI: [3.3, 17.9]
Comparison: Week 1695% CI: [5.3, 22.8]
Comparison: Week 2095% CI: [9.2, 29.5]
Comparison: Week 2495% CI: [9.8, 31.7]
Secondary
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
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. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'.
Time frame: Weeks 12, 16, 20, and 24
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 12 | 24.0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 16 | 26.9 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 20 | 25.6 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 24 | 28.8 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 24 | 48.7 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 12 | 40.2 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 20 | 52.0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 16 | 39.1 Percentage of participants |
Comparison: Week 1295% CI: [5.5, 26.8]
Comparison: Week 1695% CI: [1.3, 22.9]
Comparison: Week 2095% CI: [15.4, 37.5]
Comparison: Week 2495% CI: [8.5, 31.3]
Secondary
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24
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).
Time frame: Weeks 12, 16, 20, and 24
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 16 | 37.7 Percentage of responders |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 24 | 50.3 Percentage of responders |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 20 | 47.6 Percentage of responders |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 12 | 26.7 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 20 | 63.1 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 16 | 51.6 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 12 | 47.6 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Week 24 | 64.7 Percentage of responders |
Comparison: Week 1295% CI: [9.9, 31.8]
Comparison: Week 1695% CI: [2.5, 25.2]
Comparison: Week 2095% CI: [4.1, 27]
Comparison: Week 2495% CI: [2.9, 25.9]
Secondary
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
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). PGI responder is a response of 'very much improved' or 'much improved'.
Time frame: Weeks 12, 16, 20, and 24
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 29.8 Percentage of responders |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 33.5 Percentage of responders |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 40.9 Percentage of responders |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 46.0 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 65.5 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 52.8 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 63.4 Percentage of responders |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 55.5 Percentage of responders |
Comparison: Week 1295% CI: [11.9, 34]
Comparison: Week 1695% CI: [10.7, 33.1]
Comparison: Week 2095% CI: [11.2, 33.9]
Comparison: Week 2495% CI: [8.1, 31]
Secondary
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
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). Negative change indicates no hair loss.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: 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 analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -0.5 Percent change | Standard Deviation 11.17 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | -7.4 Percent change | Standard Deviation 18.41 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -18.1 Percent change | Standard Deviation 27.42 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -26.3 Percent change | Standard Deviation 31.68 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -32.1 Percent change | Standard Deviation 34.26 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -38.2 Percent change | Standard Deviation 36.85 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -49.0 Percent change | Standard Deviation 37.44 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -1.0 Percent change | Standard Deviation 8.73 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -39.9 Percent change | Standard Deviation 36.24 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | -14.8 Percent change | Standard Deviation 21.67 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -55.3 Percent change | Standard Deviation 38.01 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -30.9 Percent change | Standard Deviation 33.69 |
Comparison: Week 495% CI: [-2.8, 1.8]
Comparison: Week 895% CI: [-11.9, -2.7]
Comparison: Week 1295% CI: [-19.3, -5.5]
Comparison: Week 1695% CI: [-22.2, -6.9]
Comparison: Week 2095% CI: [-23.7, -7.2]
Comparison: Week 2495% CI: [-24, -6.8]
Secondary
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20.
Time frame: Weeks 28, 32, 36, 40, 44, and 48
Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 28 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 32 | 16.7 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 36 | 26.7 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 40 | 36.4 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 44 | 28.6 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 48 | 40.0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 44 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 28 | 16.7 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 40 | 22.2 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 32 | 14.3 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 48 | 28.6 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 36 | 43.8 Percentage of participants |
Secondary
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20.
Time frame: Weeks 28, 32, 36, 40, 44, and 48
Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 48 | 7.7 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 28 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 32 | 6.3 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 36 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 40 | 12.5 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 44 | 7.7 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 40 | 10.5 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 48 | 5.6 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 36 | 4.8 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 28 | 12 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 44 | 0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48 | Week 32 | 4.5 Percentage of participants |
Secondary
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment.
Time frame: Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Population: Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 8 | 100.0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 4 | 60.0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 12 | 80.0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 24 | 60.0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 20 | 60.0 Percentage of participants |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 16 | 60.0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 24 | 50.0 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 4 | 62.5 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 8 | 62.5 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 12 | 62.5 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 16 | 62.5 Percentage of participants |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 20 | 62.5 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 12 | 30.8 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 16 | 50.0 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 4 | 26.7 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 24 | 76.9 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 20 | 69.2 Percentage of participants |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 8 | 23.1 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 20 | 70.6 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 12 | 43.8 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 4 | 15.8 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 24 | 77.8 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 8 | 16.7 Percentage of participants |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24 | Week 16 | 61.1 Percentage of participants |
Secondary
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24
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).
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Population: Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -20.8 Percent change | Standard Deviation 15.27 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -54.8 Percent change | Standard Deviation 43.9 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -39.3 Percent change | Standard Deviation 53.48 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | -39.6 Percent change | Standard Deviation 20.33 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -42.6 Percent change | Standard Deviation 27.06 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -48.8 Percent change | Standard Deviation 52.66 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -11.4 Percent change | Standard Deviation 78.88 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -1.5 Percent change | Standard Deviation 69.43 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -7.8 Percent change | Standard Deviation 83.35 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -7.9 Percent change | Standard Deviation 81.41 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | 26.2 Percent change | Standard Deviation 109.97 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -2.6 Percent change | Standard Deviation 78.81 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | 10.5 Percent change | Standard Deviation 48.1 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | 12.1 Percent change | Standard Deviation 39.44 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -13.4 Percent change | Standard Deviation 95.31 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -39.3 Percent change | Standard Deviation 84.49 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -29.2 Percent change | Standard Deviation 93.24 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -7.2 Percent change | Standard Deviation 84.41 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -15.2 Percent change | Standard Deviation 116.2 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -31.5 Percent change | Standard Deviation 108.97 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -38.4 Percent change | Standard Deviation 105.8 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | 47.8 Percent change | Standard Deviation 71.19 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | 47.1 Percent change | Standard Deviation 94.35 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | 33.9 Percent change | Standard Deviation 119.41 |