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

Sun Pharmaceutical Industries, Inc.

Status and phase: Completed; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: CTP-543

Study type: Interventional

Funder types: Industry

Identifiers

NCT05041803

CP543.5002

2021-002365-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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407 participants in 1 patient group

CTP-543

Experimental group

Description:

Patients who previously completed a qualifying CTP-543 clinical trial

Treatment:

Drug: CTP-543