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

NCT ID: NCT05041803

Last Updated: 2025-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2024-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CTP-543

Patients who previously completed a qualifying CTP-543 clinical trial

Group Type EXPERIMENTAL

CTP-543

Intervention Type DRUG

Twice daily dosing

Interventions

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CTP-543

Twice daily dosing

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Dermatologie CHRU de Brest - Hopital Morvan

Brest, Finistere, France

Site Status

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

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

Site Status

CHU de Bordeaux, Hopital Saint-Andre

Bordeaux, , France

Site Status

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

La Rochelle, , France

Site Status

Hôpital La Timone-Dermatologie

Marseille, , France

Site Status

Hopital de l'Hotel Dieu - CHU de Nantes

Nantes, , France

Site Status

Hôpital Saint Louis, Centre de Santé Sabouraud

Paris, , France

Site Status

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, , France

Site Status

Universitätsklinikum Tübingen Universitäts-Hautklinik

Tübingen, Baden-Wüttermberg, Germany

Site Status

Universitätsklinikum Erlangen, Hautklinik

Erlangen, Bavaria, Germany

Site Status

Klinikum Rechts der Isar, Technische Universität München, Hautklinik

München, Bavaria, Germany

Site Status

Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt am Main, Hesse, Germany

Site Status

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, Germany

Site Status

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

Münster, North Rhine-Westphalia, Germany

Site Status

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

Berlin, , Germany

Site Status

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

Pécs, Baranya, Hungary

Site Status

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

Szeged, Csongrad-Csanad County, Hungary

Site Status

Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika

Budapest, Pest County, Hungary

Site Status

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, Poland

Site Status

ETG Siedlce

Siedlce, Masovian Voivodeship, Poland

Site Status

ETG Skierniewice

Skierniewice, Masovian Voivodeship, Poland

Site Status

RCMed Oddzial w Sochaczewie

Sochaczew, Masovian Voivodeship, Poland

Site Status

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

Warsaw, Masovian Voivodeship, Poland

Site Status

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, Masovian Voivodeship, Poland

Site Status

ETG Warszawa

Warsaw, Masovian Voivodeship, Poland

Site Status

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL

Bialystok, , Poland

Site Status

Vita Longa Sp.Zo.O

Katowice, , Poland

Site Status

Specjalistyczny Gabinet Dermatologiczny s.c.

Krakow, , Poland

Site Status

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Site Status

My Clinic

Warsaw, , Poland

Site Status

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

Site Status

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

Wroclaw, , Poland

Site Status

Hospital Clínic de Barcelona

Barcelona, Barcelona/Cataluña, Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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France Germany Hungary Poland Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2021-002365-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CP543.5002

Identifier Type: -

Identifier Source: org_study_id

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