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

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03898479

Enrollment

1000

Registered

2019-04-02

Start date

2019-04-04

Completion date

2027-06-30

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Brief 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, moderate to severe alopecia areata.

Interventions

DRUGCTP-543

Twice daily dosing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety	332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)	332 weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026