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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified September 2025 by Sun Pharmaceutical Industries, Inc.
Sponsor
Sun Pharmaceutical Industries, Inc.
Information Provided by (Responsible Party)
Sun Pharmaceutical Industries, Inc.
Clinicaltrials.gov Identifier
NCT03898479
Other Study ID Numbers:
CP543.5001
First Submitted
March 28, 2019
First Posted
April 1, 2019
Last Update Posted
October 21, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Alopecia Areata
Drug: CTP-543

Study Design

Study TypeInterventional
Actual Enrollment1000 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateApril 3, 2019
Actual Primary Completion Date11mos 3w from now
Actual Study Completion Date1yr 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
CTP-543
Patients who previously completed a qualifying CTP-543 clinical trial
Drug: CTP-543
Twice daily dosing

Outcome Measures

Primary Outcome Measures
  1. Number of Participants with Adverse Events as a Measure of Safety
  2. Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsSun Pharmaceutical Industries, Inc.
Locations
Total Skin and Beauty Dermatology Center | Birmingham Alabama, United States, 35203Alliance Dermatology & MOHS Center | Phoenix Arizona, United States, 85032Center for Dermatology and Plastic Surgery/CCT Research | Scottsdale Arizona, United States, 85260Johnson Dermatology | Fort Smith Arkansas, United States, 72916Northwest Arkansas Clinical Trials Center, PLLC | Rogers Arkansas, United States, 72758Kern Research Inc. | Bakersfield California, United States, 93301Hope Clinical Research | Canoga Park California, United States, 91303California Dermatology & Clinical Research Institute | Encinitas California, United States, 92024University of California, Irvine | Irvine California, United States, 92697Dermatology Research Associates | Los Angeles California, United States, 90045Quest Dermatology Research | Northridge California, United States, 91324Kaiser Permanente Northern California - Oakland | Oakland California, United States, 94611Palmtree Clinical Research, Inc. | Palm Springs California, United States, 92262Stanford University School of Medicine - Medical Dermatology Clinic | Redwood City California, United States, 94063Kaiser Permanente South Sacramento | Sacramento California, United States, 95823Kaiser Permanente Clinical Trials Unit | San Francisco California, United States, 94118Colorado Center for Dermatology, PLLC d/b/a CODerm Research | Centennial Colorado, United States, 80111Colorado Medical Research Center | Denver Colorado, United States, 80210Yale University Church Street Research Unit | New Haven Connecticut, United States, 06519Skin Care Research, LLC | Boca Raton Florida, United States, 33486Skin Care Research, LLC | Hollywood Florida, United States, 33021University of Miami Hospital | Miami Florida, United States, 33125Floridian Research Institute, LLC | Miami Florida, United States, 33179Lenus Research & Medical Group, LLC | Sweetwater Florida, United States, 33172Clinical Research Trials of Florida, Inc. | Tampa Florida, United States, 33607ForCare Clinical Research | Tampa Florida, United States, 33613ASR, LLC | Boise Idaho, United States, 83702Denova Research | Chicago Illinois, United States, 60611Dawes Fretzin Clinical Research Group, LLC | Indianapolis Indiana, United States, 46250DS Research | New Albany Indiana, United States, 47150The Indiana Clinical Trials Center, PC | Plainfield Indiana, United States, 46168DS Research | Louisville Kentucky, United States, 40241Qualmedica Research | Owensboro Kentucky, United States, 42301Massachusetts General Hospital | Boston Massachusetts, United States, 02114Brigham and Women's Hospital | Boston Massachusetts, United States, 02115Clarkston Skin Research | Clarkston Michigan, United States, 48346Clinical Research Institute of Michigan | Clinton Township Michigan, United States, 48038Minnesota Clinical Study Center | Fridley Minnesota, United States, 55432University of Minnesota Department of Dermatology | Minneapolis Minnesota, United States, 55417Vivida Dermatology | Las Vegas Nevada, United States, 89119Skin Laser and Surgery Specialists of NJ | Hackensack New Jersey, United States, 07601Schweiger Dermatology, P.C. | Verona New Jersey, United States, 07044Icahn School of Medicine at Mount Sinai | New York New York, United States, 10029Sadick Research Group | New York New York, United States, 10075UR Dermatology at College Town | Rochester New York, United States, 14620Dermatology Specialists of Charlotte | Charlotte North Carolina, United States, 28211Darst Dermatology | Charlotte North Carolina, United States, 28277North Carolina Dermatology Associates, PLLC | Raleigh North Carolina, United States, 27617Wake Forest University Health Sciences, Department of Dermatology | Winston-Salem North Carolina, United States, 27104Bexley Dermatology Research | Bexley Ohio, United States, 43209Remington-Davis, Inc. | Columbus Ohio, United States, 43215Vital Prospects Clinical Research Institute, P.C. | Tulsa Oklahoma, United States, 74136Oregon Medical Research Center | Portland Oregon, United States, 97201NW Dermatology Institute | Portland Oregon, United States, 97210Hospital of the University of Pennsylvania Dept of Dermatology | Philadelphia Pennsylvania, United States, 19104Dermatology Associates of Plymouth Meeting | Plymouth Meeting Pennsylvania, United States, 19462Peak Research - Pennsylvania | Upper Saint Clair Pennsylvania, United States, 15241Velocity Clinical Research-Providence | East Greenwich Rhode Island, United States, 02818Rhode Island Hospital | Providence Rhode Island, United States, 02903Clinical Research Center of the Carolinas | Charleston South Carolina, United States, 29407Palmetto Clinical Trial Services | Fountain Inn South Carolina, United States, 29644Dermatology Treatment and Research Center - Dallas | Dallas Texas, United States, 75230North Texas Center for Clinical Research | Frisco Texas, United States, 75034Suzanne Bruce and Associates, PA | Houston Texas, United States, 77056Austin Institute for Clinical Research, Inc. | Pflugerville Texas, United States, 78660Progressive Clinical Research | San Antonio Texas, United States, 78213Texas Dermatology and Laser Specialists | San Antonio Texas, United States, 78218Dermatology Clinical Research Center of San Antonio | San Antonio Texas, United States, 78229Jordan Valley Dermatology | West Jordan Utah, United States, 84088University of Virginia Health System | Charlottesville Virginia, United States, 22903West End Dermatology Associates | Richmond Virginia, United States, 23233Clinical Investigation Specialists, Inc. | Kenosha Wisconsin, United States, 53144Dermatology Research Institute | Calgary Alberta, Canada, T1Y 0B4Kirk Barber Research | Calgary Alberta, Canada, T2G 1B1Care Clinic | Red Deer Alberta, Canada, T4P 1K4Medical Arts Health Research Group | Kelowna British Columbia, Canada, V1Y 4N7Enverus Medical Research | Surrey British Columbia, Canada, V3V 0C6Wiseman Dermatology Research Inc. | Winnipeg Manitoba, Canada, R3M 3Z4SimcoDerm Medical and Surgical Dermatology Center | Barrie Ontario, Canada, L4M 7G1Kingsway Clinical Research | Etobicoke Ontario, Canada, M8X 1Y9Guelph Dermatology Research | Guelph Ontario, Canada, N1L 0B7DermEffects | London Ontario, Canada, N6H 5L5Lynderm Research Inc. | Markham Ontario, Canada, L3P 1X3Dr. S. K. Siddha Medicine Professional Corporation | Newmarket Ontario, Canada, L3Y 5G8The Centre for Clinical Trials | Oakville Ontario, Canada, L6J 7W5JRB research Inc. | Ottawa Ontario, Canada, K1K 4L2Centre for Dermatology | Richmond Hill Ontario, Canada, L4B 1A5Research Toronto | Toronto Ontario, Canada, M4W 2N4Alliance Clinical Trials | Waterloo Ontario, Canada, N2J 1C4Innovaderm Research Inc. | Montreal Quebec, Canada, H2X 2V1Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) | Québec , Canada, G1V 4X7