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

NCT05041803 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CP543.50022021-002365-18
• Study Type: interventional
• Target: 407
• Locations: 5 countries
• Sites: 39

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

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

CTP-543

EXPERIMENTAL

Patients who previously completed a qualifying CTP-543 clinical trial

Drug: CTP-543

Interventions

CTP-543 DRUG

Twice daily dosing

CTP-543

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (39)

Service de Dermatologie CHRU de Brest - Hopital Morvan

Brest, Finistere, 29609, France

Location

Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2

Nice, Provence-Alpes-Côte d'Azur Region, 06202, France

Location

CHU de Bordeaux, Hopital Saint-Andre

Bordeaux, 33000, France

Location

Hopital Saint-Louis - GH De La Rochelle-Re-Aunis

La Rochelle, 17019, France

Location

Hôpital La Timone-Dermatologie

Marseille, 13385, France

Location

Hopital de l'Hotel Dieu - CHU de Nantes

Nantes, 22093, France

Location

Hôpital Saint Louis, Centre de Santé Sabouraud

Paris, 75010, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059, France

Location

Universitätsklinikum Tübingen Universitäts-Hautklinik

Tübingen, Baden-Wüttermberg, 72076, Germany

Location

Universitätsklinikum Erlangen, Hautklinik

Erlangen, Bavaria, 91054, Germany

Location

Klinikum Rechts der Isar, Technische Universität München, Hautklinik

München, Bavaria, 80802, Germany

Location

Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)

Münster, North Rhine-Westphalia, 48149, Germany

Location

Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika

Pécs, Baranya, 7632, Hungary

Location

SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrad-Csanad County, 6720, Hungary

Location

Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika

Budapest, Pest County, 1085, Hungary

Location

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

ETG Siedlce

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

ETG Skierniewice

Skierniewice, Masovian Voivodeship, 96-100, Poland

Location

RCMed Oddzial w Sochaczewie

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o

Warsaw, Masovian Voivodeship, 00-716, Poland

Location

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, Masovian Voivodeship, 02-661, Poland

Location

ETG Warszawa

Warsaw, Masovian Voivodeship, 02-793, Poland

Location

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL

Bialystok, 15-453, Poland

Location

Vita Longa Sp.Zo.O

Katowice, 40-748, Poland

Location

Specjalistyczny Gabinet Dermatologiczny s.c.

Krakow, 30-002, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-500, Poland

Location

My Clinic

Warsaw, 00-144, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

WroMedica I. Bielicka, A. Strazalkowska s.c.

Wroclaw, 51-685, Poland

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona/Cataluña, 08036, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head, Regulatory Affairs
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

9122 66455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: October 19, 2021
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Locations

HU (3); PL (14); FR (8); ES (7); DE (7)