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

Concert Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: CTP-543

Study type: Interventional

Funder types: Industry

Identifiers

NCT03898479

CP543.5001

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, moderate to severe alopecia areata.

Enrollment: 1,000 estimated 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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1,000 participants in 1 patient group

CTP-543

Experimental group

Description:

Patients who previously completed a qualifying CTP-543 clinical trial

Treatment:

Drug: CTP-543