Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
NCT ID: NCT04797650
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
517 participants
INTERVENTIONAL
2021-06-10
2022-06-29
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.
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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Alliance Dermatology & Mohs Center
Phoenix, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
University of Miami Hospital
Miami, Florida, United States
Floridian Research Institute LLC
Miami, Florida, United States
MetroBoston Clinical Partners, LLC
Brighton, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Galen Research
Chesterfield, Missouri, United States
Vivida Dermatology
Las Vegas, Nevada, United States
The Dermatology Group P.C.
Verona, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center - Department of Dermatology
New York, New York, United States
University of Rochester
Rochester, New York, United States
Dermatologists of Southwest Ohio
Mason, Ohio, United States
Oregon Medical Research
Portland, Oregon, United States
Velocity Clinical Research - Providence
Warwick, Rhode Island, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
Elixir Research Group
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Velocity Clinical Research/Gateway
Salt Lake City, Utah, United States
Velocity Clinical Research/Swinyer-Woseth Dermatology
Salt Lake City, Utah, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, United States
Care Clinic Ltd.
Red Deer, Alberta, Canada
Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Centre de Recherche Dermatologique du Quebec Metropolitan
Québec, , Canada
Centre Hospitalier Universitaire de Nice - Hôpital Archet 2
Nice, Alpes-maritimes, France
Chru de Brest - Hôpital Morvan
Brest, Finestère, France
Universitaetsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Klinikum Rechts Der Isar, Technische Universität München
Munich, Bavaria, Germany
Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim - Dermatologische Studienambulanz
Bad Bentheim, Lower Saxony, Germany
Dermatologische Studienambulanz
Bochum, North Rhine-Westphalia, Germany
University Hospital Muenster
Münster, North Rhine-Westphalia, Germany
Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Erlangen Hautklinik
Erlangen, , Germany
Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika
Pécs, Baranya, Hungary
Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika
Szeged, Csongrád-csanád, Hungary
Bugát Pál Kórház
Gyöngyös, Heves County, Hungary
Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika
Budapest, Pest County, Hungary
Wromedica I. Bielicka, A. Strzalkowska S.C.
Wroclaw, Lower Silesian Voivodeship, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sól
Nowa Sól, Lubusz Voivodeship, Poland
Etg Siedlce
Siedlce, Masovian Voivodeship, Poland
Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.
Warsaw, Masovian Voivodeship, Poland
Rcmed Oddzial Warszawa
Warsaw, Masovian Voivodeship, Poland
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, Masovian Voivodeship, Poland
Etg Warszawa
Warsaw, Masovian Voivodeship, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Etg Skierniewice
Skierniewice, Łódź Voivodeship, Poland
Hospital Del Mar
Barcelona, Catalonia, Spain
Hospital Santa Creu I Sant Pau
Barcelona, Catalonia, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas
Madrid, , Spain
Hospital Doce de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Infanta Leonor
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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2021-000387-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP543.3002
Identifier Type: -
Identifier Source: org_study_id
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