Clinical trial NCT05041803: European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 108 weeks
measure: Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
timeFrame: 108 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brest Cedex
country: France
facility: Service de Dermatologie CHRU de Brest - Hopital Morvan
state: Finistere
city: Nice
country: France
facility: Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2
state: Provence-Alpes-Cote d'Azur
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hopital Saint-Andre
city: La Rochelle
country: France
facility: Hopital Saint-Louis - GH De La Rochelle-Re-Aunis
city: Marseille
country: France
facility: Hôpital La Timone-Dermatologie
city: Nantes
country: France
facility: Hopital de l'Hotel Dieu - CHU de Nantes
city: Paris
country: France
facility: Hôpital Saint Louis, Centre de Santé Sabouraud
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Universitäts-Hautklinik
state: Baden-Wüttermberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Hautklinik
state: Bayern
city: München
country: Germany
facility: Klinikum Rechts der Isar, Technische Universität München, Hautklinik
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Klinik für Dermatologie, Venerologie und Allergologie
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Münster
country: Germany
facility: Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika
state: Baranya County
city: Szeged
country: Hungary
facility: SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
state: Csongrad-Csanad County
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika
state: Pest
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia Centrum Medyczne Nowa Sol
state: Lubuskie
city: Siedlce
country: Poland
facility: ETG Siedlce
state: Mazowieckie
city: Skierniewice
country: Poland
facility: ETG Skierniewice
state: Mazowieckie
city: Sochaczew
country: Poland
facility: RCMed Oddzial w Sochaczewie
state: Mazowieckie
city: Warsaw
country: Poland
facility: ETG Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o
state: Mazowieckie
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
state: Mazowieckie
city: Białystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
city: Katowice
country: Poland
facility: Vita Longa Sp.Zo.O
city: Kraków
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny s.c.
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warsaw
country: Poland
facility: My Clinic
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: WroMedica I. Bielicka, A. Strazalkowska s.c.
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Barcelona/Cataluña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: