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

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: Active, not recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: CTP-543

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 2; Phase 3

Contacts and Locations

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, K1K 4L2
      • 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
    • Clinton Township, Michigan, United States, 48038
      • Clinical Research Institute of Michigan
  • 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, 28211
      • 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)	332 weeks

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

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 (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• 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