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
1 other identifier
interventional
1,000
2 countries
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
Longer than P75 for phase_2
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
April 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
October 22, 2025
October 1, 2025
8.1 years
March 29, 2019
October 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
CTP-543
EXPERIMENTALPatients who previously completed a qualifying CTP-543 clinical trial
Interventions
Eligibility Criteria
You may qualify if:
- Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35203, United States
Alliance Dermatology & MOHS Center
Phoenix, Arizona, 85032, United States
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, 85260, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758, United States
Kern Research Inc.
Bakersfield, California, 93301, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
University of California, Irvine
Irvine, California, 92697, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Quest Dermatology Research
Northridge, California, 91324, United States
Kaiser Permanente Northern California - Oakland
Oakland, California, 94611, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262, United States
Stanford University School of Medicine - Medical Dermatology Clinic
Redwood City, California, 94063, United States
Kaiser Permanente South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente Clinical Trials Unit
San Francisco, California, 94118, United States
Colorado Center for Dermatology, PLLC d/b/a CODerm Research
Centennial, Colorado, 80111, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
Yale University Church Street Research Unit
New Haven, Connecticut, 06519, United States
Skin Care Research, LLC
Boca Raton, Florida, 33486, United States
Skin Care Research, LLC
Hollywood, Florida, 33021, United States
University of Miami Hospital
Miami, Florida, 33125, United States
Floridian Research Institute, LLC
Miami, Florida, 33179, United States
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
ASR, LLC
Boise, Idaho, 83702, United States
Denova Research
Chicago, Illinois, 60611, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
DS Research
New Albany, Indiana, 47150, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
DS Research
Louisville, Kentucky, 40241, United States
Qualmedica Research
Owensboro, Kentucky, 42301, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, 48038, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55417, United States
Vivida Dermatology
Las Vegas, Nevada, 89119, United States
Skin Laser and Surgery Specialists of NJ
Hackensack, New Jersey, 07601, United States
Schweiger Dermatology, P.C.
Verona, New Jersey, 07044, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Sadick Research Group
New York, New York, 10075, United States
UR Dermatology at College Town
Rochester, New York, 14620, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28211, United States
Darst Dermatology
Charlotte, North Carolina, 28277, United States
North Carolina Dermatology Associates, PLLC
Raleigh, North Carolina, 27617, United States
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, 27104, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Remington-Davis, Inc.
Columbus, Ohio, 43215, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Oregon Medical Research Center
Portland, Oregon, 97201, United States
NW Dermatology Institute
Portland, Oregon, 97210, United States
Hospital of the University of Pennsylvania Dept of Dermatology
Philadelphia, Pennsylvania, 19104, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462, United States
Peak Research - Pennsylvania
Upper Saint Clair, Pennsylvania, 15241, United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Palmetto Clinical Trial Services
Fountain Inn, South Carolina, 29644, United States
Dermatology Treatment and Research Center - Dallas
Dallas, Texas, 75230, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Jordan Valley Dermatology
West Jordan, Utah, 84088, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
West End Dermatology Associates
Richmond, Virginia, 23233, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53144, United States
Dermatology Research Institute
Calgary, Alberta, T1Y 0B4, Canada
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Care Clinic
Red Deer, Alberta, T4P 1K4, Canada
Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9, Canada
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X3, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
JRB research Inc.
Ottawa, Ontario, K1K 4L2, Canada
Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
Research Toronto
Toronto, Ontario, M4W 2N4, Canada
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, G1V 4X7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 2, 2019
Study Start
April 4, 2019
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
October 22, 2025
Record last verified: 2025-10