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

Primary Purpose

Alopecia Areata

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CTP-543
Sponsored by
Concert Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Dermatologie CHRU de Brest - Hopital Morvan
  • Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2
  • CHU de Bordeaux, Hopital Saint-Andre
  • Hopital Saint-Louis - GH De La Rochelle-Re-Aunis
  • Hôpital La Timone-Dermatologie
  • Hopital de l'Hotel Dieu - CHU de Nantes
  • Hôpital Saint Louis, Centre de Santé Sabouraud
  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Universitätsklinikum Tübingen Universitäts-Hautklinik
  • Universitätsklinikum Erlangen, Hautklinik
  • Klinikum Rechts der Isar, Technische Universität München, Hautklinik
  • Klinik für Dermatologie, Venerologie und Allergologie
  • Fachklinik Bad Bentheim
  • Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)
  • Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
  • Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika
  • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
  • Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika
  • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • ETG Siedlce
  • ETG Skierniewice
  • RCMed Oddzial w Sochaczewie
  • ETG Warszawa
  • OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o
  • Carpe Diem Centrum Medycyny Estetycznej
  • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
  • Vita Longa Sp.Zo.O
  • Specjalistyczny Gabinet Dermatologiczny s.c.
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • My Clinic
  • Royalderm Agnieszka Nawrocka
  • WroMedica I. Bielicka, A. Strazalkowska s.c.
  • Hospital Clínic de Barcelona
  • Hospital del Mar
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario Reina Sofía
  • Hospital Universitario Ramón y Cajal
  • Hospital 12 de Octubre
  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CTP-543

Arm Description

Patients who previously completed a qualifying CTP-543 clinical trial

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety
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).

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
September 28, 2023
Sponsor
Concert Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05041803
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTP-543
Arm Type
Experimental
Arm Description
Patients who previously completed a qualifying CTP-543 clinical trial
Intervention Type
Drug
Intervention Name(s)
CTP-543
Intervention Description
Twice daily dosing
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
108 weeks
Title
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
108 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service de Dermatologie CHRU de Brest - Hopital Morvan
City
Brest Cedex
State/Province
Finistere
ZIP/Postal Code
29609
Country
France
Facility Name
Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2
City
Nice
State/Province
Provence-Alpes-Cote d'Azur
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Bordeaux, Hopital Saint-Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital Saint-Louis - GH De La Rochelle-Re-Aunis
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Hôpital La Timone-Dermatologie
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital de l'Hotel Dieu - CHU de Nantes
City
Nantes
ZIP/Postal Code
22093
Country
France
Facility Name
Hôpital Saint Louis, Centre de Santé Sabouraud
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Tübingen Universitäts-Hautklinik
City
Tübingen
State/Province
Baden-Wüttermberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Hautklinik
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum Rechts der Isar, Technische Universität München, Hautklinik
City
München
State/Province
Bayern
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klinik für Dermatologie, Venerologie und Allergologie
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika
City
Pécs
State/Province
Baranya County
ZIP/Postal Code
7632
Country
Hungary
Facility Name
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
City
Szeged
State/Province
Csongrad-Csanad County
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika
City
Budapest
State/Province
Pest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Twoja Przychodnia Centrum Medyczne Nowa Sol
City
Nowa Sól
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Facility Name
ETG Siedlce
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Facility Name
ETG Skierniewice
City
Skierniewice
State/Province
Mazowieckie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
RCMed Oddzial w Sochaczewie
City
Sochaczew
State/Province
Mazowieckie
ZIP/Postal Code
96-500
Country
Poland
Facility Name
ETG Warszawa
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-793
Country
Poland
Facility Name
OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-716
Country
Poland
Facility Name
Carpe Diem Centrum Medycyny Estetycznej
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-661
Country
Poland
Facility Name
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
City
Białystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
Vita Longa Sp.Zo.O
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Specjalistyczny Gabinet Dermatologiczny s.c.
City
Kraków
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-500
Country
Poland
Facility Name
My Clinic
City
Warsaw
ZIP/Postal Code
00-144
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka
City
Warsaw
ZIP/Postal Code
02-962
Country
Poland
Facility Name
WroMedica I. Bielicka, A. Strazalkowska s.c.
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Barcelona/Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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