Alopecia Areata
Conditions
Keywords
Alopecia, Hair loss, Hair disease, CTP-543
Brief summary
This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
Interventions
Administered as tablets.
DRUGCTP-543
Administered as tablets.
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
* 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. * 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 |
|---|---|---|
| Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 | Week 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Weeks 4, 8, 12, 16, and 20 | 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 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). |
| 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). |
| 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). |
| 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. |
| 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. |
| Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, 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). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported. |
| Percentage of Responders 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. Responders were defined as participants with responses of satisfied or very satisfied. |
| Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, and 24 | BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes. |
| Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Baseline, 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. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction. |
| Percentage of Participants Achieving a ≥2-point Change From Baseline in the 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. |
| 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 indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality. |
| Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Baseline and Week 24 | HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity. |
| Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24 | Week 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). |
| Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, and 24 | BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0 = no eyebrow, 1 = minimal eyebrow, 2 = moderate eyebrow, 3 = normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows. |
Countries
Canada, France, Poland, Spain, United States
Participant flow
Recruitment details
Participants were enrolled at study centers in Canada, France, Poland, Spain and the United States from 23 November 2020 to 19 April 2022.
Pre-assignment details
946 participants were screened, out of which 706 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 |
|---|---|
| Placebo Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | 140 |
| CTP-543 8 mg BID Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | 351 |
| CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. | 215 |
| Total | 706 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 10 | 6 |
| Overall Study | Non-compliance With Study Drug | 0 | 3 | 2 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 0 | 1 |
| Overall Study | Reason not Specified | 4 | 11 | 2 |
| Overall Study | Treatment Emergent or Worsening Adverse Event | 2 | 8 | 4 |
Baseline characteristics
| Characteristic | Placebo | CTP-543 8 mg BID | CTP-543 12 mg BID | Total |
|---|---|---|---|---|
| Age, Continuous | 38.7 years STANDARD_DEVIATION 13.81 | 38.9 years STANDARD_DEVIATION 13.32 | 38.2 years STANDARD_DEVIATION 12.8 | 38.6 years STANDARD_DEVIATION 13.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 30 Participants | 13 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants | 292 Participants | 188 Participants | 599 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 29 Participants | 14 Participants | 53 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 10 Participants | 22 Participants | 21 Participants | 53 Participants |
| Race/Ethnicity, Customized Race Black or African American | 16 Participants | 40 Participants | 27 Participants | 83 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Not reported | 10 Participants | 26 Participants | 14 Participants | 50 Participants |
| Race/Ethnicity, Customized Race Other | 5 Participants | 17 Participants | 6 Participants | 28 Participants |
| Race/Ethnicity, Customized Race White | 98 Participants | 241 Participants | 145 Participants | 484 Participants |
| Sex: Female, Male Female | 89 Participants | 217 Participants | 131 Participants | 437 Participants |
| Sex: Female, Male Male | 51 Participants | 134 Participants | 84 Participants | 269 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 351 | 0 / 215 |
| other Total, other adverse events | 31 / 140 | 117 / 350 | 75 / 215 |
| serious Total, serious adverse events | 4 / 140 | 4 / 350 | 1 / 215 |
Outcome results
Primary
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 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).
Time frame: Week 24
Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 | 0.8 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 | 29.6 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24 | 41.5 percentage of participants |
p-value: <0.000195% CI: [0.23, 0.33]Mantel Haenszel
p-value: <0.000195% CI: [0.32, 0.46]Mantel Haenszel
Secondary
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Time frame: Baseline and Week 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Depression: Change From Baseline at Week 24 | -0.7 score on a scale | Standard Deviation 2.67 |
| Placebo | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Anxiety: Change From Baseline at Week 24 | -0.4 score on a scale | Standard Deviation 2.98 |
| Placebo | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Anxiety: Baseline | 5.5 score on a scale | Standard Deviation 3.92 |
| Placebo | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Depression: Baseline | 3.3 score on a scale | Standard Deviation 3.06 |
| CTP-543 8 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Anxiety: Baseline | 6.2 score on a scale | Standard Deviation 4.06 |
| CTP-543 8 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Depression: Change From Baseline at Week 24 | -0.9 score on a scale | Standard Deviation 2.93 |
| CTP-543 8 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Depression: Baseline | 3.7 score on a scale | Standard Deviation 3.31 |
| CTP-543 8 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Anxiety: Change From Baseline at Week 24 | -1.0 score on a scale | Standard Deviation 3.26 |
| CTP-543 12 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Depression: Change From Baseline at Week 24 | -1.1 score on a scale | Standard Deviation 2.88 |
| CTP-543 12 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Depression: Baseline | 3.6 score on a scale | Standard Deviation 3.39 |
| CTP-543 12 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Anxiety: Change From Baseline at Week 24 | -1.1 score on a scale | Standard Deviation 3.24 |
| CTP-543 12 mg BID | Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24 | Anxiety: Baseline | 6.0 score on a scale | Standard Deviation 3.92 |
Comparison: Anxietyp-value: 0.248995% CI: [-0.2, 0.9]ANCOVA
Comparison: Anxietyp-value: 0.123595% CI: [-0.1, 1.1]ANCOVA
Comparison: Depressionp-value: 0.976595% CI: [-0.5, 0.5]ANCOVA
Comparison: Depressionp-value: 0.355995% CI: [-0.3, 0.8]ANCOVA
Secondary
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0 = no eyebrow, 1 = minimal eyebrow, 2 = moderate eyebrow, 3 = normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.
Time frame: Baseline, Weeks 12, 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 12 | -0.2 score on a scale | Standard Deviation 1.38 |
| Placebo | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Baseline | 1.7 score on a scale | Standard Deviation 2.05 |
| Placebo | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 24 | -0.2 score on a scale | Standard Deviation 1.68 |
| CTP-543 8 mg BID | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 12 | 0.8 score on a scale | Standard Deviation 1.7 |
| CTP-543 8 mg BID | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Baseline | 1.2 score on a scale | Standard Deviation 1.77 |
| CTP-543 8 mg BID | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 24 | 1.6 score on a scale | Standard Deviation 1.96 |
| CTP-543 12 mg BID | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Baseline | 1.4 score on a scale | Standard Deviation 1.91 |
| CTP-543 12 mg BID | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 24 | 1.8 score on a scale | Standard Deviation 2.17 |
| CTP-543 12 mg BID | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 12 | 1.1 score on a scale | Standard Deviation 2.05 |
Comparison: Week 12p-value: 0.00195% CI: [0.3, 1.2]MMRM
Comparison: Week 12p-value: <0.000195% CI: [0.6, 1.6]MMRM
Comparison: Week 24p-value: <0.000195% CI: [1.2, 2.2]MMRM
Comparison: Week 24p-value: <0.000195% CI: [1.4, 2.4]MMRM
Secondary
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.
Time frame: Baseline, Weeks 12, 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 24 | 0.3 score on a scale | Standard Deviation 1.3 |
| Placebo | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Baseline | 1.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 12 | -0.1 score on a scale | Standard Deviation 1.18 |
| CTP-543 8 mg BID | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 24 | 1.7 score on a scale | Standard Deviation 1.99 |
| CTP-543 8 mg BID | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Baseline | 1.4 score on a scale | Standard Deviation 2.1 |
| CTP-543 8 mg BID | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 12 | 0.9 score on a scale | Standard Deviation 1.5 |
| CTP-543 12 mg BID | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 24 | 2.0 score on a scale | Standard Deviation 2.28 |
| CTP-543 12 mg BID | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Baseline | 1.7 score on a scale | Standard Deviation 2.12 |
| CTP-543 12 mg BID | Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24 | Change From Baseline at Week 12 | 1.3 score on a scale | Standard Deviation 2.08 |
Comparison: Week 12p-value: <0.000195% CI: [0.5, 1.3]MMRM
Comparison: Week 12p-value: <0.000195% CI: [1, 1.8]MMRM
Comparison: Week 24p-value: <0.000195% CI: [1, 2]MMRM
Comparison: Week 24p-value: <0.000195% CI: [1.4, 2.4]MMRM
Secondary
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 in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 20 | -0.1 score on a scale | Standard Deviation 0.83 |
| Placebo | Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 16 | -0.2 score on a scale | Standard Deviation 0.99 |
| Placebo | Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 6.5 score on a scale | Standard Deviation 0.74 |
| Placebo | 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 | -0.1 score on a scale | Standard Deviation 0.74 |
| Placebo | Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 24 | -0.2 score on a scale | Standard Deviation 0.9 |
| CTP-543 8 mg BID | 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 | -1.3 score on a scale | Standard Deviation 1.55 |
| CTP-543 8 mg BID | 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 0.86 |
| CTP-543 8 mg BID | 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 | -1.0 score on a scale | Standard Deviation 1.38 |
| CTP-543 8 mg BID | 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 | -1.6 score on a scale | Standard Deviation 1.77 |
| CTP-543 8 mg BID | 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 | -1.9 score on a scale | Standard Deviation 1.89 |
| CTP-543 12 mg BID | 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 2.03 |
| CTP-543 12 mg BID | 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 | -2.2 score on a scale | Standard Deviation 1.92 |
| CTP-543 12 mg BID | 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 0.76 |
| CTP-543 12 mg BID | 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 | -1.9 score on a scale | Standard Deviation 1.77 |
| CTP-543 12 mg BID | 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 1.53 |
Comparison: Week 12p-value: <0.000195% CI: [-1.2, -0.7]MMRM
Comparison: Week 12p-value: <0.000195% CI: [-1.5, -0.9]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-1.4, -0.9]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-1.9, -1.3]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-1.8, -1.2]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-2.3, -1.6]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-2, -1.3]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-2.5, -1.7]MMRM
Secondary
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 indicate 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 in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | How Satisfied With Your Eyebrows: Change From Baseline at Week 12 | -0.2 score on a scale | Standard Deviation 0.88 |
| Placebo | 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 | -0.3 score on a scale | Standard Deviation 0.84 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | How Satisfied With Your Eyebrows: Change From Baseline at Week 16 | -0.1 score on a scale | Standard Deviation 0.9 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | Satisfied Evenness Hair Coverage: Change From Baseline at Week 24 | -0.2 score on a scale | Standard Deviation 0.84 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | How Satisfied With Your Eyebrows: Change From Baseline at Week 24 | -0.2 score on a scale | Standard Deviation 0.87 |
| Placebo | 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 | 3.8 score on a scale | Standard Deviation 1.39 |
| Placebo | 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 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | How Satisfied With Your Eyebrows: Change From Baseline at Week 20 | -0.2 score on a scale | Standard Deviation 0.88 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | How Satisfied With Your Eyelashes: Change From Baseline at Week 16 | -0.2 score on a scale | Standard Deviation 0.97 |
| Placebo | 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 | -0.3 score on a scale | Standard Deviation 0.79 |
| Placebo | 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 | -0.3 score on a scale | Standard Deviation 0.99 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | Satisfied Thickness Hair Coverage: Change From Baseline at Week 16 | -0.3 score on a scale | Standard Deviation 1.03 |
| Placebo | 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 | -0.2 score on a scale | Standard Deviation 0.95 |
| Placebo | 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 | 4.5 score on a scale | Standard Deviation 0.79 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | Satisfied Thickness Hair Coverage: Change From Baseline at Week 24 | -0.2 score on a scale | Standard Deviation 1 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | Satisfied Thickness Hair Coverage: Change From Baseline at Week 20 | -0.3 score on a scale | Standard Deviation 0.98 |
| Placebo | 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 | -0.4 score on a scale | Standard Deviation 0.98 |
| Placebo | Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24 | Satisfied Evenness Hair Coverage: Change From Baseline at Week 20 | -0.3 score on a scale | Standard Deviation 0.9 |
| Placebo | 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 | 4.6 score on a scale | Standard Deviation 0.67 |
| Placebo | 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 | -0.4 score on a scale | Standard Deviation 0.83 |
| CTP-543 8 mg BID | 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 1.28 |
| CTP-543 8 mg BID | 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 | -1.0 score on a scale | Standard Deviation 1.2 |
| CTP-543 8 mg BID | 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 | -1.3 score on a scale | Standard Deviation 1.35 |
| CTP-543 8 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.41 |
| CTP-543 8 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.24 |
| CTP-543 8 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.31 |
| CTP-543 8 mg BID | 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 | -1.0 score on a scale | Standard Deviation 1.19 |
| CTP-543 8 mg BID | 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 0.79 |
| CTP-543 8 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.26 |
| CTP-543 8 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.28 |
| CTP-543 8 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.23 |
| CTP-543 8 mg BID | 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 | 3.9 score on a scale | Standard Deviation 1.37 |
| CTP-543 8 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.36 |
| CTP-543 8 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.25 |
| CTP-543 8 mg BID | 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 | -1.4 score on a scale | Standard Deviation 1.43 |
| CTP-543 8 mg BID | 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 | -1.0 score on a scale | Standard Deviation 1.24 |
| CTP-543 8 mg BID | 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 | 4.6 score on a scale | Standard Deviation 0.76 |
| CTP-543 8 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.3 |
| CTP-543 8 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.37 |
| CTP-543 8 mg BID | 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 | -0.9 score on a scale | Standard Deviation 1.21 |
| CTP-543 12 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.37 |
| CTP-543 12 mg BID | 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 1.17 |
| CTP-543 12 mg BID | 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 1.33 |
| CTP-543 12 mg BID | 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 1.45 |
| CTP-543 12 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.33 |
| CTP-543 12 mg BID | 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 | -1.6 score on a scale | Standard Deviation 1.36 |
| CTP-543 12 mg BID | 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 | 4.6 score on a scale | Standard Deviation 0.68 |
| CTP-543 12 mg BID | 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 1.16 |
| CTP-543 12 mg BID | 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 1.34 |
| CTP-543 12 mg BID | 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 | -1.5 score on a scale | Standard Deviation 1.4 |
| CTP-543 12 mg BID | 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 | -1.6 score on a scale | Standard Deviation 1.52 |
| CTP-543 12 mg BID | 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 | 3.9 score on a scale | Standard Deviation 1.35 |
| CTP-543 12 mg BID | 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 | -1.1 score on a scale | Standard Deviation 1.34 |
| CTP-543 12 mg BID | 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 | -1.3 score on a scale | Standard Deviation 1.27 |
| CTP-543 12 mg BID | 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 | -1.4 score on a scale | Standard Deviation 1.32 |
| CTP-543 12 mg BID | 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 | -1.4 score on a scale | Standard Deviation 1.36 |
| CTP-543 12 mg BID | 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 |
| CTP-543 12 mg BID | 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 | -0.9 score on a scale | Standard Deviation 1.24 |
| CTP-543 12 mg BID | 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 | -1.2 score on a scale | Standard Deviation 1.3 |
| CTP-543 12 mg BID | 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 | 4.5 score on a scale | Standard Deviation 0.76 |
Comparison: How Satisfied With Your Eyelashes: Week 12p-value: <0.000195% CI: [-0.7, -0.3]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 12p-value: <0.000195% CI: [-0.9, -0.5]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 12p-value: <0.000195% CI: [-1.2, -0.7]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 16p-value: <0.000195% CI: [-1.1, -0.6]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 16p-value: <0.000195% CI: [-1.4, -1]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 20p-value: <0.000195% CI: [-1.2, -0.8]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 20p-value: <0.000195% CI: [-1.6, -1.1]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 24p-value: <0.000195% CI: [-1.3, -0.8]MMRM
Comparison: Satisfied Thickness Hair Coverage: Week 24p-value: <0.000195% CI: [-1.7, -1.2]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 12p-value: <0.000195% CI: [-0.8, -0.4]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 12p-value: <0.000195% CI: [-1.1, -0.7]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 16p-value: <0.000195% CI: [-0.9, -0.5]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 16p-value: <0.000195% CI: [-1.3, -0.8]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 20p-value: <0.000195% CI: [-1.1, -0.7]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 20p-value: <0.000195% CI: [-1.5, -1]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 24p-value: <0.000195% CI: [-1.2, -0.7]MMRM
Comparison: Satisfied Evenness Hair Coverage: Week 24p-value: <0.000195% CI: [-1.5, -1]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 12p-value: <0.000195% CI: [-0.9, -0.5]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 12p-value: <0.000195% CI: [-1.1, -0.6]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 16p-value: <0.000195% CI: [-1.1, -0.7]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 16p-value: <0.000195% CI: [-1.4, -0.9]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 20p-value: <0.000195% CI: [-1.1, -0.7]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 20p-value: <0.000195% CI: [-1.3, -0.9]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 24p-value: <0.000195% CI: [-1.2, -0.8]MMRM
Comparison: How Satisfied With Your Eyebrows: Week 24p-value: <0.000195% CI: [-1.4, -0.9]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 12p-value: <0.000195% CI: [-0.8, -0.4]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 16p-value: <0.000195% CI: [-0.9, -0.5]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 16p-value: <0.000195% CI: [-1.1, -0.7]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 20p-value: <0.000195% CI: [-0.9, -0.5]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 20p-value: <0.000195% CI: [-1, -0.5]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 24p-value: <0.000195% CI: [-1.1, -0.6]MMRM
Comparison: How Satisfied With Your Eyelashes: Week 24p-value: <0.000195% CI: [-1.2, -0.7]MMRM
Secondary
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: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 20 | -0.3 score on a scale | Standard Deviation 1.01 |
| Placebo | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 16 | -0.2 score on a scale | Standard Deviation 0.78 |
| Placebo | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 6.5 score on a scale | Standard Deviation 0.76 |
| Placebo | 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 | -0.4 score on a scale | Standard Deviation 1.08 |
| Placebo | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 24 | -0.1 score on a scale | Standard Deviation 0.74 |
| CTP-543 8 mg BID | 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 | -1.5 score on a scale | Standard Deviation 1.83 |
| CTP-543 8 mg BID | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 6.5 score on a scale | Standard Deviation 0.8 |
| CTP-543 8 mg BID | 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 1.64 |
| CTP-543 8 mg BID | 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 | -1.8 score on a scale | Standard Deviation 2.01 |
| CTP-543 8 mg BID | 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 | -1.9 score on a scale | Standard Deviation 2.05 |
| CTP-543 12 mg BID | 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 | -2.4 score on a scale | Standard Deviation 2.14 |
| CTP-543 12 mg BID | 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 | -2.2 score on a scale | Standard Deviation 2.07 |
| CTP-543 12 mg BID | 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 0.86 |
| CTP-543 12 mg BID | 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 | -2.0 score on a scale | Standard Deviation 1.95 |
| CTP-543 12 mg BID | 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 | -1.4 score on a scale | Standard Deviation 1.79 |
Comparison: Week 12p-value: <0.000195% CI: [-0.9, -0.3]MMRM
Comparison: Week 12p-value: <0.000195% CI: [-1.3, -0.6]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-1.6, -0.9]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-2.1, -1.4]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-1.7, -1]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-2.3, -1.5]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-2, -1.3]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-2.6, -1.8]MMRM
Secondary
Change in the SPRO Scale From Baseline 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. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.
Time frame: Baseline, Weeks 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 20 | -0.4 score on a scale | Standard Deviation 1.14 |
| Placebo | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 24 | -0.3 score on a scale | Standard Deviation 1.09 |
| Placebo | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 16 | -0.4 score on a scale | Standard Deviation 1.18 |
| Placebo | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 12 | -0.6 score on a scale | Standard Deviation 1.15 |
| Placebo | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 4.5 score on a scale | Standard Deviation 0.86 |
| CTP-543 8 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 20 | -1.4 score on a scale | Standard Deviation 1.52 |
| CTP-543 8 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 4.5 score on a scale | Standard Deviation 0.89 |
| CTP-543 8 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 12 | -1.3 score on a scale | Standard Deviation 1.42 |
| CTP-543 8 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 24 | -1.5 score on a scale | Standard Deviation 1.54 |
| CTP-543 8 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 16 | -1.4 score on a scale | Standard Deviation 1.44 |
| CTP-543 12 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 24 | -1.9 score on a scale | Standard Deviation 1.64 |
| CTP-543 12 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Baseline | 4.5 score on a scale | Standard Deviation 0.85 |
| CTP-543 12 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 16 | -1.8 score on a scale | Standard Deviation 1.43 |
| CTP-543 12 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 20 | -1.8 score on a scale | Standard Deviation 1.52 |
| CTP-543 12 mg BID | Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24 | Change From Baseline at Week 12 | -1.7 score on a scale | Standard Deviation 1.36 |
Comparison: Week 12p-value: <0.000195% CI: [-1, -0.5]MMRM
Comparison: Week 12p-value: <0.000195% CI: [-1.3, -0.8]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-1.2, -0.8]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-1.6, -1.1]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-1.3, -0.8]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-1.7, -1.2]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-1.5, -1]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-1.8, -1.3]MMRM
Secondary
Percentage of Participants Achieving a ≥2-point Change From Baseline in the 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.
Time frame: Weeks 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) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 12 | 20.7 percentage of participants |
| Placebo | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 16 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 20 | 13.7 percentage of participants |
| Placebo | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 24 | 12.5 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 24 | 49.1 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 12 | 44.7 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 20 | 47.5 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 16 | 48.1 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 24 | 58.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 16 | 53.9 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 20 | 57.5 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24 | Week 12 | 53.1 percentage of participants |
Comparison: Week 12p-value: <0.000195% CI: [0.17, 0.34]Mantel Haenszel
Comparison: Week 12p-value: <0.000195% CI: [0.23, 0.42]Mantel Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.27, 0.42]Mantel Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.3, 0.48]Mantel Haenszel
Comparison: Week 20p-value: <0.000195% CI: [0.26, 0.42]Mantel Haenszel
Comparison: Week 20p-value: <0.000195% CI: [0.34, 0.51]Mantel Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.29, 0.44]Mantel Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.35, 0.53]Mantel Haenszel
Secondary
Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 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).
Time frame: Week 24
Population: Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24 | 0 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24 | 20.8 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24 | 34.5 percentage of participants |
p-value: <0.000195% CI: [0.16, 0.25]Mantel Haenszel
p-value: <0.000195% CI: [0.27, 0.39]Mantel Haenszel
Secondary
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
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).
Time frame: Weeks 4, 8, 12, 16, and 20
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) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 4 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 8 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 12 | 0.7 percentage of participants |
| Placebo | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 16 | 2.3 percentage of participants |
| Placebo | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 20 | 0.8 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 8 | 3.3 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 12 | 10.4 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 20 | 24.1 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 16 | 16.5 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 4 | 0.9 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 16 | 29.6 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 8 | 6.1 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 20 | 37.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 4 | 0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Week 12 | 18.2 percentage of participants |
Comparison: Week 4p-value: 0.081695% CI: [0, 0.02]Mantel Haenszel
Comparison: Week 8p-value: 0.000595% CI: [0.01, 0.05]Mantel Haenszel
Comparison: Week 8p-value: 0.000295% CI: [0.03, 0.09]Mantel Haenszel
Comparison: Week 12p-value: <0.000195% CI: [0.06, 0.14]Mantel Haenszel
Comparison: Week 12p-value: <0.000195% CI: [0.12, 0.22]Mantel Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.1, 0.19]Mantel Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.2, 0.33]Mantel Haenszel
Comparison: Week 20p-value: <0.000195% CI: [0.19, 0.28]Mantel Haenszel
Comparison: Week 20p-value: <0.000195% CI: [0.28, 0.41]Mantel Haenszel
Secondary
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 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). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.
Time frame: Baseline, Weeks 12, 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) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 75% Relative Reduction: Week 12 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 90% Relative Reduction: Week 12 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 90% Relative Reduction: Week 24 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 75% Relative Reduction: Week 24 | 0 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 90% Relative Reduction: Week 12 | 3.4 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 75% Relative Reduction: Week 12 | 8.8 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 75% Relative Reduction: Week 24 | 28.6 percentage of participants |
| CTP-543 8 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 90% Relative Reduction: Week 24 | 19.2 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 90% Relative Reduction: Week 12 | 10.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 75% Relative Reduction: Week 24 | 40.0 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 75% Relative Reduction: Week 12 | 17.7 percentage of participants |
| CTP-543 12 mg BID | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | 90% Relative Reduction: Week 24 | 32.0 percentage of participants |
Comparison: 75% Relative Reduction: Week 12p-value: <0.000195% CI: [0.06, 0.12]Mantel Haenszel
Comparison: 75% Relative Reduction: Week 12p-value: <0.000195% CI: [0.12, 0.22]Mantel Haenszel
Comparison: 75% Relative Reduction: Week 24p-value: <0.000195% CI: [0.23, 0.33]Mantel Haenszel
Comparison: 75% Relative Reduction: Week 24p-value: <0.000195% CI: [0.32, 0.45]Mantel Haenszel
Comparison: 90% Relative Reduction: Week 12p-value: 0.000695% CI: [0.02, 0.06]Mantel Haenszel
Comparison: 90% Relative Reduction: Week 12p-value: <0.000195% CI: [0.06, 0.14]Mantel Haenszel
Comparison: 90% Relative Reduction: Week 24p-value: <0.000195% CI: [0.15, 0.23]Mantel Haenszel
Comparison: 90% Relative Reduction: Week 24p-value: <0.000195% CI: [0.24, 0.37]Mantel Haenszel
Secondary
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 in the study and dispensed study drug during the treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 9.4 percentage of responders |
| Placebo | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 3.7 percentage of responders |
| Placebo | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 8.4 percentage of responders |
| Placebo | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 7.7 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 49.1 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 53.8 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 44.2 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 36.3 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 59.8 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 54.7 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 57.1 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 43.5 percentage of responders |
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
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).
Time frame: Weeks 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) |
|---|---|---|---|
| Placebo | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 10.0 percentage of responders |
| Placebo | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 10.2 percentage of responders |
| Placebo | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 9.0 percentage of responders |
| Placebo | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 6.7 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 38.9 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 49.1 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 24 | 56.6 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 50.6 percentage of responders |
| CTP-543 12 mg BID | 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 |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 12 | 49.8 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 16 | 58.3 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Week 20 | 60.0 percentage of responders |
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Responders 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. Responders were defined as participants with responses of satisfied or very satisfied.
Time frame: Weeks 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) |
|---|---|---|---|
| Placebo | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 12 | 11.9 percentage of responders |
| Placebo | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 16 | 8.3 percentage of responders |
| Placebo | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 20 | 6.1 percentage of responders |
| Placebo | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 24 | 4.7 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 24 | 42.1 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 12 | 35.3 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 20 | 37.4 percentage of responders |
| CTP-543 8 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 16 | 38.2 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 24 | 53.0 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 16 | 51.5 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 20 | 54.0 percentage of responders |
| CTP-543 12 mg BID | Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Week 12 | 46.4 percentage of responders |
Comparison: Week 12p-value: <0.000195% CI: [0.17, 0.32]Mantel Haenszel
Comparison: Week 12p-value: <0.000195% CI: [0.26, 0.43]Mantel Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.24, 0.38]Mantel Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.35, 0.51]Mantel Haenszel
Comparison: Week 20p-value: <0.000195% CI: [0.26, 0.39]Mantel Haenszel
Comparison: Week 20p-value: <0.000195% CI: [0.39, 0.55]Mantel Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.31, 0.44]Mantel Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.39, 0.55]Mantel Haenszel
Secondary
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).
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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -1.5 percent change | Standard Deviation 23.3 |
| Placebo | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -0.6 percent change | Standard Deviation 16.63 |
| Placebo | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -1.3 percent change | Standard Deviation 22.14 |
| Placebo | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -0.2 percent change | Standard Deviation 5.59 |
| Placebo | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -1.8 percent change | Standard Deviation 21.06 |
| Placebo | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | -2.3 percent change | Standard Deviation 11.41 |
| CTP-543 8 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -30.3 percent change | Standard Deviation 34.2 |
| CTP-543 8 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -36.0 percent change | Standard Deviation 37.82 |
| CTP-543 8 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | -10.9 percent change | Standard Deviation 21 |
| CTP-543 8 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -41.2 percent change | Standard Deviation 39.37 |
| CTP-543 8 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -2.6 percent change | Standard Deviation 12.79 |
| CTP-543 8 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -22.2 percent change | Standard Deviation 29.45 |
| CTP-543 12 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 24 | -50.4 percent change | Standard Deviation 41.52 |
| CTP-543 12 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 4 | -4.0 percent change | Standard Deviation 12.03 |
| CTP-543 12 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 8 | 17.5 percent change | Standard Deviation 27.16 |
| CTP-543 12 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 12 | -31.1 percent change | Standard Deviation 35.53 |
| CTP-543 12 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 16 | -41.2 percent change | Standard Deviation 38.95 |
| CTP-543 12 mg BID | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Relative Change From Baseline at Week 20 | -46.8 percent change | Standard Deviation 41.32 |
Comparison: Week 4p-value: 0.056495% CI: [-4.4, 0.1]MMRM
Comparison: Week 4p-value: 0.005495% CI: [-5.9, -1]MMRM
Comparison: Week 8p-value: <0.000195% CI: [-12.7, -4.3]MMRM
Comparison: Week 8p-value: <0.000195% CI: [-19.5, -10.3]MMRM
Comparison: Week 12p-value: <0.000195% CI: [-27.5, -16]MMRM
Comparison: Week 12p-value: <0.000195% CI: [-36.3, -23.8]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-35.1, -21.8]MMRM
Comparison: Week 16p-value: <0.000195% CI: [-45.7, -31.3]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-42.1, -27.7]MMRM
Comparison: Week 20p-value: <0.000195% CI: [-52.3, -36.8]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-46.7, -31.8]MMRM
Comparison: Week 24p-value: <0.000195% CI: [-55.1, -39]MMRM