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

April 2, 2024 updated by: Concert Pharmaceuticals

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research
      • Calgary, Alberta, Canada, T1Y 0B4
        • Dermatology Research Institute
      • Red Deer, Alberta, Canada, T4P 1K4
        • Care Clinic
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • Medical Arts Health Research Group
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Center
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research
      • Guelph, Ontario, Canada, N1L 0B7
        • Guelph Dermatology Research
      • London, Ontario, Canada, N6H 5L5
        • Dermeffects
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc.
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Dr. S. K. Siddha Medicine Professional Corporation
      • Oakville, Ontario, Canada, L6J 7W5
        • The Centre for Clinical Trials
      • Ottawa, Ontario, Canada, K1H 7X3
        • JRB research Inc.
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • Centre for Dermatology
      • Toronto, Ontario, Canada, M4W 2N4
        • Research Toronto
      • Waterloo, Ontario, Canada, N2J 1C4
        • Alliance Clinical Trials
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Total Skin and Beauty Dermatology Center
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology & MOHS Center
      • Scottsdale, Arizona, United States, 85260
        • Center for Dermatology and Plastic Surgery/CCT Research
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Johnson Dermatology
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center, PLLC
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research Inc.
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Northridge, California, United States, 91324
        • Quest Dermatology Research
      • Oakland, California, United States, 94611
        • Kaiser Permanente Northern California - Oakland
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research, Inc.
      • Redwood City, California, United States, 94063
        • Stanford University School of Medicine - Medical Dermatology Clinic
      • Sacramento, California, United States, 95823
        • Kaiser Permanente South Sacramento
      • San Francisco, California, United States, 94118
        • Kaiser Permanente Clinical Trials Unit
    • Colorado
      • Centennial, Colorado, United States, 80111
        • Colorado Center for Dermatology, PLLC d/b/a CODerm Research
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University Church Street Research Unit
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, Llc
      • Hollywood, Florida, United States, 33021
        • Skin Care Research, Llc
      • Miami, Florida, United States, 33125
        • University of Miami Hospital
      • Miami, Florida, United States, 33179
        • Floridian Research Institute, LLC
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group, LLC
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida, Inc.
    • Idaho
      • Boise, Idaho, United States, 83702
        • ASR, LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • DeNova Research
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, United States, 47150
        • Ds Research
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Ds Research
      • Owensboro, Kentucky, United States, 42301
        • Qualmedica Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Clarkston Skin Research
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
      • Minneapolis, Minnesota, United States, 55417
        • University of Minnesota Department of Dermatology
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Vivida Dermatology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Skin Laser and Surgery Specialists of NJ
      • Verona, New Jersey, United States, 07044
        • Schweiger Dermatology, P.C.
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10075
        • Sadick Research Group
      • Rochester, New York, United States, 14620
        • UR Dermatology at College Town
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Darst Dermatology
      • Charlotte, North Carolina, United States, 28277
        • Dermatology Specialists of Charlotte
      • Raleigh, North Carolina, United States, 27617
        • North Carolina Dermatology Associates, PLLC
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest University Health Sciences, Department of Dermatology
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
      • Columbus, Ohio, United States, 43215
        • Remington-Davis, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute, P.C.
    • Oregon
      • Portland, Oregon, United States, 97210
        • NW Dermatology Institute
      • Portland, Oregon, United States, 97201
        • Oregon Medical Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania Dept of Dermatology
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Dermatology Associates of Plymouth Meeting
      • Upper Saint Clair, Pennsylvania, United States, 15241
        • Peak Research - Pennsylvania
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research-Providence
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas
      • Fountain Inn, South Carolina, United States, 29644
        • Palmetto Clinical Trial Services
    • Texas
      • Dallas, Texas, United States, 75230
        • Dermatology Treatment and Research Center - Dallas
      • Frisco, Texas, United States, 75034
        • North Texas Center for Clinical Research
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates, PA
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc.
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Dermatology
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
      • Richmond, Virginia, United States, 23233
        • West End Dermatology Associates
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Clinical Investigation Specialists, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety
Time Frame: 276 weeks
276 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
Time Frame: 276 weeks
276 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concert Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP543.5001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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