Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
NCT ID: NCT04518995
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
706 participants
INTERVENTIONAL
2020-11-23
2022-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
CTP-543 matching placebo
Administered as tablets.
CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
CTP-543
Administered as tablets.
CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
CTP-543
Administered as tablets.
Interventions
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CTP-543 matching placebo
Administered as tablets.
CTP-543
Administered as tablets.
CTP-543
Administered as tablets.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
* Treatment with systemic immunosuppressive medications within 3 months of Screening or during 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, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
18 Years
65 Years
ALL
No
Sponsors
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Concert Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
Kern Research, Inc.
Bakersfield, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
UC Irvine Dermatology Clinical Research Center
Irvine, California, United States
Quest Dermatology Research
Northridge, California, United States
Kaiser Permanente
Oakland, California, United States
Kaiser Permanente South Sacramento
Sacramento, California, United States
Kaiser Permanente
San Francisco, California, United States
Colorado Center for Dermatology and Skin Surgery
Centennial, Colorado, United States
Colorado Medical Research Center
Denver, Colorado, United States
Yale University, Church Street Research Unit
New Haven, Connecticut, United States
Lenus Research & Medical Group, LLC
Sweetwater, Florida, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States
Forward Clinical Trials Inc.
Tampa, Florida, United States
Denova Research
Chicago, Illinois, United States
Northwestern Memorial Hospital, Department of Dermatology
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DS Research
New Albany, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
DS Research
Louisville, Kentucky, United States
Qualmedica Research LLC
Owensboro, Kentucky, United States
Massachusetts General Hospital - Clinic
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clarkston Skin Research
Clarkston, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States
Skin Laser and Surgery Specialists of NJ
Hackensack, New Jersey, United States
Sadick Research Group
New York, New York, United States
Darst Dermatology
Charlotte, North Carolina, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, United States
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Northwest Dermatology Institute
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
PEAK Research
Upper Saint Clair, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Palmetto Clinical Trial Services
Fountain Inn, South Carolina, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Austin Institute for Clinical Research, Inc.
Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
West End Dermatology Associates
Richmond, Virginia, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
Dermatology Research Institute
Calgary, Alberta, Canada
Kirk Barber Research
Calgary, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
The Centre for Clinical Trials
Oakville, Ontario, Canada
JRB Research Inc.
Ottawa, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
Innovaderm Research Inc. - Clinic
Montreal, Quebec, Canada
Hôpital Saint-André - Chu de Bordeaux
Bordeaux, Nouvelle-Aquitaine, France
Hôpital Saint-Louis - Gh de La Rochelle
La Rochelle, Nouvelle-Aquitaine, France
Hôpital Hotel Dieu - Chu de Nantes
Nantes, Pays de la Loire Region, France
Hôpital La Timone-Dermatologie
Marseille, , France
Hôpital Saint Louis, Centre de Santé Sabouraud
Paris, , France
Vita Longa Sp.Zo.O
Katowice, , Poland
SGD S.C.
Krakow, , Poland
My Clinic
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Hospital Clínico Y Provincial de Barcelona
Barcelona, , Spain
H. U. Ramón y Cajal
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-002704-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP543.3001
Identifier Type: -
Identifier Source: org_study_id
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