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

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, moderate to severe alopecia areata.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dermatology Research Institute, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTP-543

Drug

Twice daily dosing

Primary outcomes

Number of Participants with Adverse Events as a Measure of Safety

Time frame: 332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)

Time frame: 332 weeks

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2027
First posted: Apr 2, 2019
Registry last updated: Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting