European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
- Registration Number
- NCT05041803
- Lead Sponsor
- Concert Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
- Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CTP-543 CTP-543 Patients who previously completed a qualifying CTP-543 clinical trial
- Primary Outcome Measures
Name Time Method Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) 108 weeks SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Number of Participants with Adverse Events as a Measure of Safety 108 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Hospital 12 de Octubre
馃嚜馃嚫Madrid, Spain
Hospital del Mar
馃嚜馃嚫Barcelona, Spain
Hospital de La Santa Creu i Sant Pau
馃嚜馃嚫Barcelona, Spain
Vita Longa Sp.Zo.O
馃嚨馃嚤Katowice, Poland
WroMedica I. Bielicka, A. Strazalkowska s.c.
馃嚨馃嚤Wroclaw, Poland
Hospital Universitario Ram贸n y Cajal
馃嚜馃嚫Madrid, Spain
RCMed Oddzial w Sochaczewie
馃嚨馃嚤Sochaczew, Mazowieckie, Poland
Specjalistyczny Gabinet Dermatologiczny s.c.
馃嚨馃嚤Krak贸w, Poland
Hospital Universitario La Paz
馃嚜馃嚫Madrid, Spain
Hospital Cl铆nic de Barcelona
馃嚜馃嚫Barcelona, Barcelona/Catalu帽a, Spain
Hospital Universitario Reina Sof铆a
馃嚜馃嚫C贸rdoba, Spain
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
馃嚟馃嚭Szeged, Csongrad-Csanad County, Hungary
OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o
馃嚨馃嚤Warszawa, Mazowieckie, Poland
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika
馃嚟馃嚭P茅cs, Baranya County, Hungary
ETG Skierniewice
馃嚨馃嚤Skierniewice, Mazowieckie, Poland
Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika
馃嚟馃嚭Budapest, Pest, Hungary
Twoja Przychodnia Centrum Medyczne Nowa Sol
馃嚨馃嚤Nowa S贸l, Lubuskie, Poland
Carpe Diem Centrum Medycyny Estetycznej
馃嚨馃嚤Warszawa, Mazowieckie, Poland
ETG Siedlce
馃嚨馃嚤Siedlce, Mazowieckie, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
馃嚨馃嚤Szczecin, Poland
ETG Warszawa
馃嚨馃嚤Warsaw, Mazowieckie, Poland
My Clinic
馃嚨馃嚤Warsaw, Poland
Royalderm Agnieszka Nawrocka
馃嚨馃嚤Warsaw, Poland
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
馃嚨馃嚤Bia艂ystok, Poland
CHU de Bordeaux, Hopital Saint-Andre
馃嚝馃嚪Bordeaux, France
Service de Dermatologie CHRU de Brest - Hopital Morvan
馃嚝馃嚪Brest Cedex, Finistere, France
Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2
馃嚝馃嚪Nice, Provence-Alpes-Cote d'Azur, France
H么pital La Timone-Dermatologie
馃嚝馃嚪Marseille, France
Hopital Saint-Louis - GH De La Rochelle-Re-Aunis
馃嚝馃嚪La Rochelle, France
Hopital de l'Hotel Dieu - CHU de Nantes
馃嚝馃嚪Nantes, France
H么pital Saint Louis, Centre de Sant茅 Sabouraud
馃嚝馃嚪Paris, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
馃嚝馃嚪Toulouse, France
Universit盲tsklinikum T眉bingen Universit盲ts-Hautklinik
馃嚛馃嚜T眉bingen, Baden-W眉ttermberg, Germany
Universit盲tsklinikum Erlangen, Hautklinik
馃嚛馃嚜Erlangen, Bayern, Germany
Klinikum Rechts der Isar, Technische Universit盲t M眉nchen, Hautklinik
馃嚛馃嚜M眉nchen, Bayern, Germany
Fachklinik Bad Bentheim
馃嚛馃嚜Bad Bentheim, Niedersachsen, Germany
Klinik f眉r Dermatologie, Venerologie und Allergologie
馃嚛馃嚜Frankfurt am Main, Hessen, Germany
Klinik f眉r Dermatologie und Venerologie, Zentrale Studienkoordination f眉r innovative Dermatologie (ZiD)
馃嚛馃嚜M眉nster, Nordrhein-Westfalen, Germany
Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charit茅 Universit盲tsmedizin Berlin
馃嚛馃嚜Berlin, Germany