Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
NCT ID: NCT03137381
Last Updated: 2022-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2017-08-09
2019-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1: CTP-543 4 mg BID
Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.
CTP-543
Administered as tablets.
Cohort 2: CTP-543 8 mg BID
Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.
CTP-543
Administered as tablets.
Cohort 3: CTP-543 12 mg BID
Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.
CTP-543
Administered as tablets.
Combined Placebo
Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
CTP-543 matching placebo
Administered as tablets.
Interventions
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CTP-543
Administered as tablets.
CTP-543 matching placebo
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.
* Clinical lab results within the normal range
Exclusion Criteria
* Treatment with systemic immunosuppressive medications or biologics.
* Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study
18 Years
65 Years
ALL
No
Sponsors
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Concert Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Colleen E. Hamilton
Role: STUDY_DIRECTOR
Concert Pharmaceuticals, Inc.
Locations
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University of California, Irvine
Irvine, California, United States
Contour Dermatology & Cosmetic Surgery Center
Rancho Mirage, California, United States
Stanford University School of Medicine
Redwood City, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Siperstein Dermatology Group
Boynton Beach, Florida, United States
Northwestern University
Chicago, Illinois, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Northwest Dermatology
Portland, Oregon, United States
Suzanne Bruce & Associates, PA
Houston, Texas, United States
Countries
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References
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Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 2019 American Academy of Dermatology Meeting; 01-05 March 2019; Washington, DC. Abstract 11291.
Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 11th World Congress Hair Research; 24-27 April 2019; Sitges, Barcelona.
Cassella J, Hamilton C, von Hehn J, Braman V. CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate to severe alopecia areata. In: Proceedings from the 28th EADV Congress; 09-13 October 2019, Madrid, Spain. D3T01.1: Late breaking news.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP543.2001
Identifier Type: -
Identifier Source: org_study_id
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