Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

Last updated: April 7, 2023
Sponsor: Concert Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Hair Loss

Alopecia

Treatment

CTP-543

CTP-543 matching placebo

Clinical Study ID

NCT04518995
CP543.3001
2020-002704-40
  • 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: 706
Treatment Group(s): 2
Primary Treatment: CTP-543
Phase: 3
Study Start date:
November 23, 2020
Estimated Completion Date:
April 19, 2022

Connect with a study center

  • Dermatology Research Institute

    Calgary, Alberta T1Y 0B4
    Canada

    Site Not Available

  • Kirk Barber Research

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Guelph Dermatology Research

    Guelph, Ontario N1L 0B7
    Canada

    Site Not Available

  • Dr Wei Jing Loo Medicine Professional Corporation

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • The Centre for Clinical Trials

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • JRB Research Inc.

    Ottawa, Ontario K1H 7X3
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Innovaderm Research Inc. - Clinic

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Hôpital Saint-André - Chu de Bordeaux

    Bordeaux, Nouvelle-aquitaine 33075
    France

    Site Not Available

  • Hôpital Saint-Louis - Gh de La Rochelle

    La Rochelle, Nouvelle-aquitaine 17000
    France

    Site Not Available

  • Hôpital Hotel Dieu - Chu de Nantes

    Nantes, PAYS DE LA Loire 44093
    France

    Site Not Available

  • Hôpital La Timone-Dermatologie

    Marseille, 13385
    France

    Site Not Available

  • Hôpital Saint Louis, Centre de Santé Sabouraud

    Paris, 75010
    France

    Site Not Available

  • Vita Longa Sp.Zo.O

    Katowice, 40-748
    Poland

    Site Not Available

  • SGD S.C.

    Krakow, 31-147
    Poland

    Site Not Available

  • My Clinic

    Warsaw, 00-144
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962
    Poland

    Site Not Available

  • Hospital Clínico Y Provincial de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • H. U. Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Total Skin and Beauty Dermatology Center

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Kern Research, Inc.

    Bakersfield, California 93301
    United States

    Site Not Available

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

  • UC Irvine Dermatology Clinical Research Center

    Irvine, California 92697
    United States

    Site Not Available

  • Quest Dermatology Research

    Northridge, California 91324
    United States

    Site Not Available

  • Kaiser Permanente

    Oakland, California 94611
    United States

    Site Not Available

  • Kaiser Permanente South Sacramento

    Sacramento, California 95823
    United States

    Site Not Available

  • Kaiser Permanente

    San Francisco, California 94118
    United States

    Site Not Available

  • San Luis Dermatology & Laser Clinic, Inc.

    San Luis Obispo, California 93405
    United States

    Site Not Available

  • Mosaic Dermatology

    Santa Monica, California 90403
    United States

    Site Not Available

  • Kaiser Permanente

    Vallejo, California 94589
    United States

    Site Not Available

  • Colorado Center for Dermatology and Skin Surgery

    Centennial, Colorado 80111
    United States

    Site Not Available

  • Colorado Medical Research Center

    Denver, Colorado 80210
    United States

    Site Not Available

  • Yale University, Church Street Research Unit

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Siperstein Dermatology Group

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Universal Medical and Research Center, LLC

    Miami, Florida 33126
    United States

    Site Not Available

  • Lenus Research & Medical Group, LLC

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Clinical Research Trials of Florida, Inc.

    Tampa, Florida 33607
    United States

    Site Not Available

  • Forward Clinical Trials Inc.

    Tampa, Florida 33624
    United States

    Site Not Available

  • MedaPhase, Inc.

    Newnan, Georgia 30263
    United States

    Site Not Available

  • Georgia Skin & Cancer Center

    Savannah, Georgia 31419
    United States

    Site Not Available

  • Denova Research

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital, Department of Dermatology

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • DS Research

    New Albany, Indiana 47150
    United States

    Site Not Available

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Kansas Medical Clinic, PA, dba KMC Shawnee Dermatology

    Topeka, Kansas 66606
    United States

    Site Not Available

  • DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Qualmedica Research LLC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital - Clinic

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Clarkston Skin Research

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • University of Minnesota Department of Dermatology

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Skin Laser and Surgery Specialists of NJ

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Sadick Research Group

    New York, New York 10075
    United States

    Site Not Available

  • Darst Dermatology

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Dermatology Specialists of Charlotte

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Wake Forest University Health Sciences, Department of Dermatology

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Northwest Dermatology Institute

    Portland, Oregon 97210
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Dermatology Associates Of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • PEAK Research

    Upper Saint Clair, Pennsylvania 15241
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • PEAK Research

    Fort Mill, South Carolina 29708
    United States

    Site Not Available

  • Palmetto Clinical Trial Services

    Fountain Inn, South Carolina 29644
    United States

    Site Not Available

  • Bellaire Dermatology Associates

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dermatology Treatment and Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Houston, Texas 77056
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Katy, Texas 77056
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • West End Dermatology Associates

    Richmond, Virginia 23233
    United States

    Site Not Available

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

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