Status:
COMPLETED
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.
Eligibility Criteria
Inclusion
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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 :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT04784533
Start Date
February 26 2021
End Date
May 16 2023
Last Update
October 9 2024
Active Locations (39)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, United States, 85260
3
Kern Research, Inc.
Bakersfield, California, United States, 93301
4
Hope Clinical Research
Canoga Park, California, United States, 91303