A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
NCT ID: NCT05437263
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
241 participants
INTERVENTIONAL
2022-10-31
2026-07-31
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
TRIPLE
Study Groups
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Brepocitinib Dose Level 1 PO QD
Brepocitinib
Oral Brepocitinib
Brepocitinib Dose Level 2 PO QD
Brepocitinib
Oral Brepocitinib
Placebo PO QD
Placebo
Oral Placebo
Interventions
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Brepocitinib
Oral Brepocitinib
Placebo
Oral Placebo
Eligibility Criteria
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Inclusion Criteria
* Adult subjects (18-75 years old)
* Active muscle and skin disease at screening and baseline
* Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
* Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2.
Exclusion Criteria
* Dermatomyositis with irreversible muscle involvement
* History of:
* Any lymphoproliferative disorder
* Active malignancy;
* History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
* Cancer-associated dermatomyositis
* Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
* Participants at a risk of thrombosis or cardiovascular disease
* Participants with a high risk for herpes zoster reactivation
* Participants with active or recent infections
18 Years
75 Years
ALL
No
Sponsors
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Priovant Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Scottsdale, Arizona, United States
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Irvine, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Boynton Beach, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Manhasset, New York, United States
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New York, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Jackson, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Quilmes, Buenos Aires, Argentina
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Caba, Buenos Aires F.D., Argentina
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Mendoza, , Argentina
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Leuven, , Belgium
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Vancouver, British Colombia, Canada
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Newmarket, Ontario, Canada
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Concepción, Región del Biobío, Chile
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Recoleta, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Prague, , Czechia
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Mainz, Rhineland-Palatinate, Germany
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Berlin, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Ashkelon, , Israel
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Haifa, , Israel
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Poria – Neve Oved, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Bari, , Italy
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Pavia, , Italy
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Roma, , Italy
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Torino, , Italy
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Monterrey, Nuevo León, Mexico
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Mérida, Yucatán, Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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San Luis Potosí City, , Mexico
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Nijmegen, Gelderland, Netherlands
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Amsterdam, , Netherlands
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Bialystok, Podlaskie Voivodeship, Poland
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Krakow, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Nowa Sól, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Vila Nova de Gaia, Porto District, Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Belgrade, , Serbia
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Seoul, , South Korea
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Suwon, , South Korea
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Madrid, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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İzmit, , Turkey (Türkiye)
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Bath, , United Kingdom
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Manchester, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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Related Links
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Study Website
Other Identifiers
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2022-500367-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
PVT-2201-301
Identifier Type: -
Identifier Source: org_study_id
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