NCT05041803

European 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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	CTP-543	Twice daily dosing

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2021-09-13
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

39 sites across 5 countries: France, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study