CompletedPhase 3

European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

France407 participantsStarted 2021-10-19

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Adverse Events as a Measure of Safety

Timeframe: 108 weeks

Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108

Timeframe: 108 weeks

Trial details

NCT IDNCT05041803

SponsorSun Pharmaceutical Industries, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-18

Results submitted2025-07-17

View on ClinicalTrials.gov More Alopecia Areata trials