A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
NCT ID: NCT04784533
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
317 participants
INTERVENTIONAL
2021-02-26
2023-05-16
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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Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.
CTP-543
Oral dosing
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
CTP-543
Oral dosing
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
CTP-543
Oral dosing
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
CTP-543
Oral dosing
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
Placebo
Oral dosing
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
Placebo
Oral dosing
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
CTP-543
Oral dosing
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
CTP-543
Oral dosing
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
CTP-543
Oral dosing
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
CTP-543
Oral dosing
Interventions
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CTP-543
Oral dosing
Placebo
Oral dosing
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, PC
Birmingham, Alabama, United States
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, United States
Kern Research, Inc.
Bakersfield, California, United States
Hope Clinical Research
Canoga Park, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
University of California, Irvine
Irvine, California, United States
Quest Dermatology Research
Northridge, California, United States
Kaiser Permanente
Oakland, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, 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, Inc.
Denver, Colorado, United States
Yale University Church Street Research Unit
New Haven, Connecticut, United States
Skin Care Research, LLC
Boca Raton, Florida, United States
Skin Care Research, LLC
Hollywood, Florida, United States
DeNova Research
Chicago, Illinois, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
DS Research
Louisville, Kentucky, United States
Michigan Center for Research Company, LLC
Clarkston, Michigan, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Skin Laser and Surgery Specialists of New Jersey
Hackensack, New Jersey, United States
Darst Dermatology
Charlotte, North Carolina, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, United States
North Carolina Dermatology Associates, PLLC
Raleigh, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Remington Davis
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Northwest Dermatology
Portland, Oregon, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
PEAK Research, LLC
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
Dermatology Treatment and Research Center, PA
Dallas, Texas, United States
Austin Institute for Clinical Research
Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Springville Dermatology/CCT Research
Springville, Utah, United States
West End Dermatology Associates
Richmond, Virginia, United States
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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CP543.2004
Identifier Type: -
Identifier Source: org_study_id
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