Phase 3
N=407
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT05041803 ↗Enrolled (actual)
407
Serious AEs
3.3%
Results posted
Nov 2025
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety — 308; 224 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CTP-543 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety |
308; 224 | — |
| PRIMARY Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 |
-96.38; -88.57; -90.25 | — |
Summary
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.
Eligibility Criteria
Inclusion Criteria
- Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
Exclusion Criteria
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
- Donation of blood at any point throughout the study and for 30 days after last dose of study medication
Data sourced from ClinicalTrials.gov (NCT05041803). 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.