Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

Last updated: June 30, 2023
Sponsor: Concert Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Alopecia

Hair Loss

Treatment

CTP-543 matching placebo

CTP-543

Clinical Study ID

NCT04797650
CP543.3002
2021-000387-30
  • Ages 18-65
  • All Genders

Study Summary

This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical presentation compatible with alopecia areata with a current episode lastingat least 6 months and not exceeding 10 years at the time of Screening. Total diseaseduration greater than 10 years is permitted.
  • At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
  • Willing to comply with the study visits and requirements of the study protocol.

Exclusion

Exclusion Criteria:

  • Treatment with other medications or agents within 1 month of Baseline or during thestudy that may affect hair regrowth or immune response.
  • Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topicaltreatment to the scalp, significant trauma to the scalp, or other scalp condition thatmay interfere with the SALT assessment, or untreated actinic keratosis anywhere on thebody at Screening and/or Baseline.
  • Treatment with systemic immunosuppressive medications within 3 months of Screening orduring the study, or biologics within 6 months of Screening or during the study.
  • Females who are nursing, pregnant, or planning to become pregnant while in the study,and for 30 days after last dose of study drug.
  • Clinically significant medical condition, psychiatric disease, or social condition, asdetermined by the Investigator, that may unfavorably alter the risk-benefit of studyparticipation, adversely affect study compliance, or confound interpretation of studyresults.

Study Design

Total Participants: 517
Treatment Group(s): 2
Primary Treatment: CTP-543 matching placebo
Phase: 3
Study Start date:
June 10, 2021
Estimated Completion Date:
June 29, 2022

Connect with a study center

  • Care Clinic Ltd.

    Red Deer, Alberta T4N6V7
    Canada

    Site Not Available

  • Medical Arts Health Research Group

    Kelowna, British Columbia V1Y 4N7
    Canada

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X1Y9
    Canada

    Site Not Available

  • North Bay Dermatology Centre

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • The Centre for Dermatology

    Richmond Hill, Ontario L4B1A5
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique du Quebec Metropolitan

    Quebec, L4B1A5
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W4R4
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hôpital Archet 2

    Nice, Alpes-maritimes 06202 CEDEX 3
    France

    Site Not Available

  • Chru de Brest - Hôpital Morvan

    Brest, Finestère 29609 CEDEX
    France

    Site Not Available

  • Universitaetsklinikum Tübingen

    Tübingen, Baden-württemberg 72076
    Germany

    Site Not Available

  • Klinikum Rechts Der Isar, Technische Universität München

    Munich, Bayern 80802
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie

    Frankfurt am main, Hessen 60590
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim - Dermatologische Studienambulanz

    Bad Bentheim, Niedersachsen 48455
    Germany

    Site Not Available

  • Dermatologische Studienambulanz

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • University Hospital Muenster

    Münster, Nordrhein-westfalen 48149
    Germany

    Site Not Available

  • Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen Hautklinik

    Erlangen, 91054
    Germany

    Site Not Available

  • Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika

    Pécs, Baranya 7632
    Hungary

    Site Not Available

  • Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika

    Szeged, Csongrád-csanád 6720
    Hungary

    Site Not Available

  • Bugát Pál Kórház

    Gyöngyös, Heves 3200
    Hungary

    Site Not Available

  • Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika

    Budapest, Pest 1085
    Hungary

    Site Not Available

  • Wromedica I. Bielicka, A. Strzalkowska S.C.

    Wrocław, Dolnośląskie 50-685
    Poland

    Site Not Available

  • Twoja Przychodnia - Centrum Medyczne Nowa Sól

    Nowa Sól, Lubuskie 67-100
    Poland

    Site Not Available

  • Etg Siedlce

    Siedlce, Mazowieckie 08-110
    Poland

    Site Not Available

  • Carpe Diem Centrum Medycyny Estetycznej

    Warszawa, Mazowieckie 02-664
    Poland

    Site Not Available

  • Etg Warszawa

    Warszawa, Mazowieckie 02-793
    Poland

    Site Not Available

  • Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.

    Warszawa, Mazowieckie 00-716
    Poland

    Site Not Available

  • Rcmed Oddzial Warszawa

    Warszawa, Mazowieckie 00-892
    Poland

    Site Not Available

  • Etg Skierniewice

    Skierniewice, Łódzkie 96-100
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Hospital Del Mar

    Barcelona, Cataluña 08001
    Spain

    Site Not Available

  • Hospital Santa Creu I Sant Pau

    Barcelona, Cataluña 08041
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Doce de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, 28081
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas

    Madrid, 28034
    Spain

    Site Not Available

  • Alliance Dermatology & Mohs Center

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Floridian Research Institute LLC

    Miami, Florida 33145
    United States

    Site Not Available

  • University of Miami Hospital

    Miami, Florida 33124
    United States

    Site Not Available

  • MedaPhase, Inc.

    Newnan, Georgia 30263
    United States

    Site Not Available

  • MetroBoston Clinical Partners, LLC

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48087
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Galen Research

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Vivida Dermatology

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • The Dermatology Group P.C.

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Columbia University Medical Center - Department of Dermatology

    New York, New York 10032
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio

    Mason, Ohio 45040
    United States

    Site Not Available

  • Oregon Medical Research

    Portland, Oregon 97223
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • The Skin Wellness Center

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Site Not Available

  • Elixir Research Group

    Houston, Texas 77077
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Velocity Clinical Research/Gateway

    Salt Lake City, Utah 84101
    United States

    Site Not Available

  • Velocity Clinical Research/Swinyer-Woseth Dermatology

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Jordan Valley Dermatology Center

    West Jordan, Utah 84088
    United States

    Site Not Available

  • The Rector and Visitors of the University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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