Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata

Concert Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: CTP-543 matching placebo; Drug: CTP-543

Study type: Interventional

Funder types: Industry

Identifiers

NCT03137381

CP543.2001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.

Full description

This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Participants will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
• At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
• Clinical lab results within the normal range

Exclusion criteria

• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
• Treatment with systemic immunosuppressive medications or biologics.
• Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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149 participants in 4 patient groups, including a placebo group

Cohort 1: CTP-543 4 mg BID

Experimental group

Description:

Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.

Treatment:

Drug: CTP-543

Cohort 2: CTP-543 8 mg BID

Experimental group

Description:

Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.

Treatment:

Drug: CTP-543

Cohort 3: CTP-543 12 mg BID

Experimental group

Description:

Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.

Treatment:

Drug: CTP-543

Combined Placebo

Placebo Comparator group

Description:

Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.

Treatment:

Drug: CTP-543 matching placebo