| 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). | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.8
- OG00129.6
- OG00241.5
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mantel Haenszel | | <0.0001 | P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo. | Risk Difference (RD) | 0.28 | Standard Error of the Mean | 0.026 | 2-Sided | 95 | 0.23 | 0.33 | | | | | Superiority | | | |
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| 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". | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of responders | | Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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). | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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). | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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). | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of responders | | Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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). | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of responders | | Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 |
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| 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. | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of participants | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 12, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | |
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| 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. | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of participants | | Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Weeks 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. |
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| 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). | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. | | OG001 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | | OG002 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
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