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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: CTP-543

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux, Hôpital Saint-André
  • La Rochelle, France, 17019
    • Hopital Saint-Louis - GH De La Rochelle-Re-Aunis
  • Marseille, France, 13385
    • Hôpital La Timone-Dermatologie
  • Nantes, France, 22093
    • Hopital de l'Hotel Dieu - CHU de Nantes
  • Paris, France, 75010
    • Hôpital Saint Louis, Centre de Santé Sabouraud
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Finistere
    • Brest, Finistere, France, 29609
      • Service de Dermatologie CHRU de Brest - Hopital Morvan
  • Provence-Alpes-Côte d'Azur Region
    • Nice, Provence-Alpes-Côte d'Azur Region, France, 06202
      • Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2
• Germany
  • Berlin, Germany, 10117
    • Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
  • Baden-Wüttermberg
    • Tübingen, Baden-Wüttermberg, Germany, 72076
      • Universitätsklinikum Tübingen Universitäts-Hautklinik
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitätsklinikum Erlangen, Hautklinik
    • München, Bavaria, Germany, 80802
      • Klinikum Rechts der Isar, Technische Universität München, Hautklinik
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Klinik für Dermatologie, Venerologie und Allergologie
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)
• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika
  • Csongrad-Csanad County
    • Szeged, Csongrad-Csanad County, Hungary, 6720
      • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
  • Pest County
    • Budapest, Pest County, Hungary, 1085
      • Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika
• Poland
  • Bialystok, Poland, 15-453
    • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
  • Katowice, Poland, 40-748
    • Vita Longa Sp.Zo.O
  • Krakow, Poland, 30-002
    • Specjalistyczny Gabinet Dermatologiczny s.c.
  • Szczecin, Poland, 71-500
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warsaw, Poland, 02-962
    • Royalderm Agnieszka Nawrocka
  • Warsaw, Poland, 00-144
    • My clinic
  • Wroclaw, Poland, 51-685
    • WroMedica I. Bielicka, A. Strazalkowska s.c.
  • Lubusz Voivodeship
    • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
      • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Masovian Voivodeship
    • Siedlce, Masovian Voivodeship, Poland, 08-110
      • ETG Siedlce
    • Skierniewice, Masovian Voivodeship, Poland, 96-100
      • ETG Skierniewice
    • Sochaczew, Masovian Voivodeship, Poland, 96-500
      • RCMed Oddzial w Sochaczewie
    • Warsaw, Masovian Voivodeship, Poland, 00-716
      • OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o
    • Warsaw, Masovian Voivodeship, Poland, 02-661
      • Carpe Diem Centrum Medycyny Estetycznej
    • Warsaw, Masovian Voivodeship, Poland, 02-793
      • ETG Warszawa
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Barcelona/Cataluña
    • Barcelona, Barcelona/Cataluña, Spain, 08036
      • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTP-543; Patients who previously completed a qualifying CTP-543 clinical trial	Drug: CTP-543; Twice daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety		108 weeks
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100*(post-baseline value - baseline)/baseline.	108 weeks

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: CP543.5002; 2021-002365-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No