Phase 2
N=149
Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT03137381 ↗Enrolled (actual)
149
Serious AEs
0.7%
Results posted
Jul 2022
Primary outcome: Primary: Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 — 9.3; 21.4; 47.4; 58.3 Percentage of participants — p=0.177
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CTP-543 (Drug); CTP-543 matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Concert Pharmaceuticals
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 |
9.3; 21.4; 47.4; 58.3 | 0.177 |
| PRIMARY Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) |
31; 25; 31; 30 | — |
Summary
This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.
Eligibility Criteria
Inclusion Criteria
- Definitive diagnosis of 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.
- Clinical lab results within the normal range
Exclusion Criteria
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
- Treatment with systemic immunosuppressive medications or biologics.
- Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study
Data sourced from ClinicalTrials.gov (NCT03137381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.