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
| Verified date | May 2024 |
| Source | Concert Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Concert Pharmaceuticals |
France, Germany, Hungary, Poland, Spain,
| 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 |
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