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ACTIVE NOT RECRUITING
NCT05437263
PHASE3

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

Sponsor: Priovant Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

241

Start Date

2022-10-31

Completion Date

2026-07

Last Updated

2025-09-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

Brepocitinib

Oral Brepocitinib

DRUG

Placebo

Oral Placebo

Locations (109)

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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, 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