Clinical Trials Logo
  1. Home
  2. Alopecia Areata
  3. NCT05041803
  4. Details
NCT05041803 Clinical Trial

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

Alopecia Areata Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05041803
Other study ID # CP543.5002
Secondary ID 2021-002365-18
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 19, 2021
Est. completion date July 2024

Study information
Verified date April 2024
Source Concert Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 407
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CTP-543
Twice daily dosing

Locations
Country Name City State
France CHU de Bordeaux, Hopital Saint-Andre Bordeaux
France Service de Dermatologie CHRU de Brest - Hopital Morvan Brest Cedex Finistere
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 Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2 Nice Provence-Alpes-Cote d'Azur
France Hôpital Saint Louis, Centre de Santé Sabouraud Paris
France Centre Hospitalier Universitaire de Toulouse - Hopital Larrey Toulouse
Germany Fachklinik Bad Bentheim Bad Bentheim Niedersachsen
Germany Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Erlangen, Hautklinik Erlangen Bayern
Germany Klinik für Dermatologie, Venerologie und Allergologie Frankfurt am Main Hessen
Germany Klinikum Rechts der Isar, Technische Universität München, Hautklinik München Bayern
Germany Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD) Münster Nordrhein-Westfalen
Germany Universitätsklinikum Tübingen Universitäts-Hautklinik Tübingen Baden-Wüttermberg
Hungary Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika Budapest Pest
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika Pécs Baranya County
Hungary SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika Szeged Csongrad-Csanad County
Poland NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL Bialystok
Poland Vita Longa Sp.Zo.O Katowice
Poland Specjalistyczny Gabinet Dermatologiczny s.c. Kraków
Poland Twoja Przychodnia Centrum Medyczne Nowa Sol Nowa Sól Lubuskie
Poland ETG Siedlce Siedlce Mazowieckie
Poland ETG Skierniewice Skierniewice Mazowieckie
Poland RCMed Oddzial w Sochaczewie Sochaczew Mazowieckie
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland ETG Warszawa Warsaw Mazowieckie
Poland My Clinic Warsaw
Poland Royalderm Agnieszka Nawrocka Warsaw
Poland Carpe Diem Centrum Medycyny Estetycznej Warszawa Mazowieckie
Poland OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o Warszawa Mazowieckie
Poland WroMedica I. Bielicka, A. Strazalkowska s.c. Wroclaw
Spain Hospital Clínic de Barcelona Barcelona Barcelona/Cataluña
Spain Hospital de La Santa Creu i Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Reina Sofía Córdoba
Spain Hospital 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramón y Cajal Madrid

Sponsors (1)
Lead Sponsor Collaborator
Concert Pharmaceuticals

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety 108 weeks
Primary Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). 108 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05051761 - Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata Phase 3
Active, not recruiting NCT03570749 - A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Phase 2/Phase 3
Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Active, not recruiting NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A