Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Purpose
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.
Condition
- Alopecia Areata
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Placebo |
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. |
|
|
Experimental CTP-543 8 mg BID |
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. |
|
|
Placebo Comparator CTP-543 12 mg BID |
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- Concert Pharmaceuticals