A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)

Concert Pharmaceuticals69 sites in 2 countries706 target enrollmentNovember 23, 2020

ConditionsAlopecia Areata

InterventionsCTP-543 matching placebo CTP-543

DrugsCTP-543 matching placebo CTP-543

Overview

Phase: Phase 3
Intervention: CTP-543 matching placebo
Conditions: Alopecia Areata
Sponsor: Concert Pharmaceuticals
Enrollment: 706
Locations: 69
Primary Endpoint: Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 23, 2020

End Date

April 19, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Concert Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Placebo

Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.

Intervention: CTP-543 matching placebo

CTP-543 8 mg BID

Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.

Intervention: CTP-543

CTP-543 12 mg BID

Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.

Intervention: CTP-543

Outcomes

Primary Outcomes

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24

Time Frame: 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 Outcomes

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)
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)
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)
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)
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)
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)
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24(Baseline, Weeks 12, and 24)
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)
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)
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)
Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24(Week 24)
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24(Baseline, Weeks 12, and 24)
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24(Baseline, Weeks 12, 16, 20, and 24)
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)
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)