Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2022
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT04797650
Start Date
June 10 2021
End Date
June 29 2022
Last Update
July 3 2023
Active Locations (63)
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1
Alliance Dermatology & Mohs Center
Phoenix, Arizona, United States, 85032
2
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
3
Dermatology Research Associates
Los Angeles, California, United States, 90045
4
University of Miami Hospital
Miami, Florida, United States, 33124