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

Phase 3

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: CTP-543

• Registration Number: NCT05041803
• Lead Sponsor: Sun Pharmaceutical Industries, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Study Start: 2021-10-19
• Primary Completion: 2024-07-18
• Study Completion: 2024-07-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CTP-543	CTP-543	Patients who previously completed a qualifying CTP-543 clinical trial

Primary Outcome Measures

Name	Time	Method
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)	108 weeks	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Number of Participants with Adverse Events as a Measure of Safety	108 weeks

Trial Locations

Locations (39)

Service de Dermatologie CHRU de Brest - Hopital Morvan; 🇫🇷 Brest Cedex, Finistere, France

Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2; 🇫🇷 Nice, Provence-Alpes-Cote d'Azur, France

CHU de Bordeaux, Hopital Saint-Andre; 🇫🇷 Bordeaux, France

Hopital Saint-Louis - GH De La Rochelle-Re-Aunis; 🇫🇷 La Rochelle, France

Hôpital La Timone-Dermatologie; 🇫🇷 Marseille, France

Hopital de l'Hotel Dieu - CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Saint Louis, Centre de Santé Sabouraud; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey; 🇫🇷 Toulouse, France

Universitätsklinikum Tübingen Universitäts-Hautklinik; 🇩🇪 Tübingen, Baden-Wüttermberg, Germany

Universitätsklinikum Erlangen, Hautklinik; 🇩🇪 Erlangen, Bayern, Germany

Scroll for more (29 remaining)