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

Sponsor

Concert Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05041803

Collaborator

(none)

300

Enrollment

Locations

Arm

19.4

Anticipated Duration (Months)

7.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: CTP-543	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTP-543 Patients who previously completed a qualifying CTP-543 clinical trial	Drug: CTP-543 Twice daily dosing

Arm

Intervention/Treatment

Experimental: CTP-543

Patients who previously completed a qualifying CTP-543 clinical trial

Drug: CTP-543

Twice daily dosing

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety [52 weeks]
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) [52 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Dermatologie CHRU de Brest - Hopital Morvan	Brest Cedex	Finistere	France	29609
2	Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2	Nice	Provence-Alpes-Cote d'Azur	France	06202
3	CHU de Bordeaux, Hopital Saint-Andre	Bordeaux		France	33000
4	Hopital Saint-Louis - GH De La Rochelle-Re-Aunis	La Rochelle		France	17019
5	Hôpital La Timone-Dermatologie	Marseille		France	13385
6	Hopital de l'Hotel Dieu - CHU de Nantes	Nantes		France	22093
7	Hôpital Saint Louis, Centre de Santé Sabouraud	Paris		France	75010
8	Centre Hospitalier Universitaire de Toulouse - Hopital Larrey	Toulouse		France	31059
9	Universitätsklinikum Tübingen Universitäts-Hautklinik	Tübingen	Baden-Wüttermberg	Germany	72076
10	Universitätsklinikum Erlangen, Hautklinik	Erlangen	Bayern	Germany	91054
11	Klinikum Rechts der Isar, Technische Universität München, Hautklinik	München	Bayern	Germany	80802
12	Klinik für Dermatologie, Venerologie und Allergologie	Frankfurt am Main	Hessen	Germany	60590
13	Fachklinik Bad Bentheim	Bad Bentheim	Niedersachsen	Germany	48455
14	Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)	Münster	Nordrhein-Westfalen	Germany	48149
15	Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin	Berlin		Germany	10117
16	Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika	Pécs	Baranya County	Hungary	7632
17	SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika	Szeged	Csongrad-Csanad County	Hungary	6720
18	Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika	Budapest	Pest	Hungary	1085
19	Twoja Przychodnia Centrum Medyczne Nowa Sol	Nowa Sól	Lubuskie	Poland	67-100
20	ETG Siedlce	Siedlce	Mazowieckie	Poland	08-110
21	ETG Skierniewice	Skierniewice	Mazowieckie	Poland	96-100
22	ETG Warszawa	Warsaw	Mazowieckie	Poland	02-793
23	OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o	Warszawa	Mazowieckie	Poland	00-716
24	RCMed Oddzial Warszawa	Warszawa	Mazowieckie	Poland	00-896
25	Carpe Diem Centrum Medycyny Estetycznej	Warszawa	Mazowieckie	Poland	02-661
26	NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL	Białystok		Poland	15-453
27	Vita Longa Sp.Zo.O	Katowice		Poland	40-748
28	SGD S.C.	Kraków		Poland	31-147
29	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin		Poland	71-434
30	My Clinic	Warsaw		Poland	00-144
31	Royalderm Agnieszka Nawrocka	Warsaw		Poland	02-962
32	WroMedica I. Bielicka, A. Strazalkowska s.c.	Wroclaw		Poland	51-685
33	Hospital Clínic de Barcelona	Barcelona	Barcelona/Cataluña	Spain	08036
34	Hospital del Mar	Barcelona		Spain	08003
35	Hospital de La Santa Creu i Sant Pau	Barcelona		Spain	08041
36	Hospital Universitario Reina Sofía	Córdoba		Spain	14004
37	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
38	Hospital 12 de Octubre	Madrid		Spain	28041
39	Hospital Universitario La Paz	Madrid		Spain	28046

Sponsors and Collaborators

Concert Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Concert Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05041803

Other Study ID Numbers:

CP543.5002
2021-002365-18

First Posted:

Sep 13, 2021

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Study Results

No Results Posted as of Jul 27, 2022