Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

• Status: Completed
• Trial end date: 2019-11-21
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, multi-center study to evaluate the efficacy and tolerability of once-daily versus twice daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concert Pharmaceuticals

Criteria

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 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