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

Last updated: September 23, 2025
Sponsor: Priovant Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Collagen Vascular Diseases

Lupus

Connective Tissue Diseases

Treatment

Brepocitinib

Placebo

Clinical Study ID

NCT05437263
PVT-2201-301
2022-500367-12-00
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteriafor Idiopathic Inflammatory Myopathies

  • Adult subjects (18-75 years old)

  • Active muscle and skin disease at screening and baseline

  • Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/orone non-steroid immunosuppressant

  • Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.

Exclusion

Exclusion Criteria:

  • Dermatomyositis with end-stage organ involvement

  • Dermatomyositis with irreversible muscle involvement

  • History of:

  • Any lymphoproliferative disorder

  • Active malignancy;

  • History of cancer within 5 years prior to randomization (exceptions for basalcell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of thebreast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)

  • Cancer-associated dermatomyositis

  • Overlap myositis/connective tissue disease (except for overlap with Sjögren'ssyndrome)

  • Participants at a risk of thrombosis or cardiovascular disease

  • Participants with a high risk for herpes zoster reactivation

  • Participants with active or recent infections

Study Design

Total Participants: 241
Treatment Group(s): 2
Primary Treatment: Brepocitinib
Phase: 3
Study Start date:
October 31, 2022
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Clinical Trial Site

    Quilmes, Buenos Aires B1878DVB
    Argentina

    Site Not Available

  • Clinical Trial Site

    Quilmes 3429652, Buenos Aires 3435907 B1878DVB
    Argentina

    Site Not Available

  • Clinical Trial Site

    Caba, Buenos Aires F.D. 3433955 1425
    Argentina

    Site Not Available

  • Clinical Trial Site

    Mendoza, 5519
    Argentina

    Site Not Available

  • Clinical Trial Site

    Mendoza 3844421, 5519
    Argentina

    Site Not Available

  • Clinical Trial Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Clinical Trial Site

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Clinical Trial Site

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Plovdiv 728193, 4001
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Sofia 727011, 1407
    Bulgaria

    Site Not Available

  • Clinical Trial Site

    Vancouver, British Colombia V5Y1K2
    Canada

    Site Not Available

  • Clinical Trial Site

    Vancouver 6173331, British Colombia V5Y1K2
    Canada

    Site Not Available

  • Clinical Trial Site

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Clinical Trial Site

    Newmarket 6087701, Ontario 6093943 L3Y 5G8
    Canada

    Site Not Available

  • Clinical Trial Site

    Concepción, Region Del Bio Bio 4070280
    Chile

    Site Not Available

  • Clinical Trial Site

    Concepción 3893894, Región del Biobío 3898380 4070280
    Chile

    Site Not Available

  • Clinical Trial Site

    Recoleta, 8420383
    Chile

    Site Not Available

  • Clinical Trial Site

    Recoleta 3873635, 8420383
    Chile

    Site Not Available

  • Clinical Trial Site

    Santiago, 8331150
    Chile

    Site Not Available

  • Clinical Trial Site

    Santiago 3871336, 8331150
    Chile

    Site Not Available

  • Clinical Trial Site

    Temuco, 4800827
    Chile

    Site Not Available

  • Clinical Trial Site

    Temuco 3870011, 4800827
    Chile

    Site Not Available

  • Clinical Trial Site

    Prague, 128 00
    Czechia

    Site Not Available

  • Clinical Trial Site

    Prague 3067696, 128 00
    Czechia

    Site Not Available

  • Clinical Trial Site

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Clinical Trial Site

    Mainz 2874225, Rhineland-Palatinate 2847618 55131
    Germany

    Site Not Available

  • Clinical Trial Site

    Berlin, 15562
    Germany

    Site Not Available

  • Clinical Trial Site

    Berlin 2950159, 15562
    Germany

    Site Not Available

  • Clinical Trial Site

    Dresden, 01307
    Germany

    Site Not Available

  • Clinical Trial Site

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Clinical Trial Site

    Essen, 45147
    Germany

    Site Not Available

  • Clinical Trial Site

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Clinical Trial Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Clinical Trial Site

    Freiburg im Breisgau 2925177, 79106
    Germany

    Site Not Available

  • Clinical Trial Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • Clinical Trial Site

    Debrecen 721472, 4032
    Hungary

    Site Not Available

  • Clinical Trial Site

    Pécs, 7632
    Hungary

    Site Not Available

  • Clinical Trial Site

    Pécs 3046526, 7632
    Hungary

    Site Not Available

  • Clinical Trial Site

    Szeged, 6720
    Hungary

    Site Not Available

  • Clinical Trial Site

    Szeged 715429, 6720
    Hungary

    Site Not Available

  • Clinical Trial Site

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Clinical Trial Site

    Ashkelon 295620, 7830604
    Israel

    Site Not Available

  • Clinical Trial Site

    Haifa, 3109601
    Israel

    Site Not Available

  • Clinical Trial Site

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Clinical Trial Site

    Poria – Neve Oved 293906, 1528001
    Israel

    Site Not Available

  • Clinical Trial Site

    Poriyya, 1528001
    Israel

    Site Not Available

  • Clinical Trial Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Clinical Trial Site

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Clinical Trial Site

    Tel HaShomer, 52621
    Israel

    Site Not Available

  • Clinical Trial Site

    Tel Litwinsky 293361, 52621
    Israel

    Site Not Available

  • Clinical Trial Site

    Bari, 70126
    Italy

    Site Not Available

  • Clinical Trial Site

    Bari 3182351, 70126
    Italy

    Site Not Available

  • Clinical Trial Site

    Pavia, 27100
    Italy

    Site Not Available

  • Clinical Trial Site

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • Clinical Trial Site

    Roma, 00168
    Italy

    Site Not Available

  • Clinical Trial Site

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Clinical Trial Site

    Torino, 10126
    Italy

    Site Not Available

  • Clinical Trial Site

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Clinical Trial Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Monterrey, Nuevo Leon 64718
    Mexico

    Site Not Available

  • Clinical Trial Site

    Monterrey 3995465, Nuevo León 3522542 64718
    Mexico

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  • Clinical Trial Site

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • Clinical Trial Site

    Mérida 3523349, Yucatán 3514211 97070
    Mexico

    Site Not Available

  • Clinical Trial Site

    Guadalajara, 44690
    Mexico

    Site Not Available

  • Clinical Trial Site

    Guadalajara 4005539, 44690
    Mexico

    Site Not Available

  • Clinical Trial Site

    Mexico City, 06700
    Mexico

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  • Clinical Trial Site

    Mexico City 3530597, 06700
    Mexico

    Site Not Available

  • Clinical Trial Site

    San Luis Potosí, 78290
    Mexico

    Site Not Available

  • Clinical Trial Site

    San Luis Potosí City 3985606, 78290
    Mexico

    Site Not Available

  • Clinical Trial Site

    Nijmegen, Gelderland 6500 HB
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Nijmegen 2750053, Gelderland 2755634 6500 HB
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Amsterdam, 1105 AZ
    Netherlands

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  • Clinical Trial Site

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Białystok, Podlaskie 15-704
    Poland

    Site Not Available

  • Clinical Trial Site

    Bialystok 776069, Podlaskie Voivodeship 858789 15-704
    Poland

    Site Not Available

  • Clinical Trial Site

    Krakow 3094802, 30-363
    Poland

    Site Not Available

  • Clinical Trial Site

    Kraków, 30-363
    Poland

    Site Not Available

  • Clinical Trial Site

    Lublin, 20-400
    Poland

    Site Not Available

  • Clinical Trial Site

    Lublin 765876, 20-607
    Poland

    Site Not Available

  • Clinical Trial Site

    Nowa Sól, 67-100
    Poland

    Site Not Available

  • Clinical Trial Site

    Nowa Sól 3090764, 67-100
    Poland

    Site Not Available

  • Clinical Trial Site

    Poznan 3088171, 61-293
    Poland

    Site Not Available

  • Clinical Trial Site

    Poznań, 61-293
    Poland

    Site Not Available

  • Clinical Trial Site

    Warsaw, 02-637
    Poland

    Site Not Available

  • Clinical Trial Site

    Warsaw 756135, 02-637
    Poland

    Site Not Available

  • Clinical Trial Site

    Vila Nova De Gaia, Porto 4434-502
    Portugal

    Site Not Available

  • Clinical Trial Site

    Vila Nova de Gaia 2732544, Porto District 2735941 4434-502
    Portugal

    Site Not Available

  • Clinical Trial Site

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • Clinical Trial Site

    Guimarães 2738752, 4835-044
    Portugal

    Site Not Available

  • Clinical Trial Site

    Lisboa, 1649-028
    Portugal

    Site Not Available

  • Clinical Trial Site

    Lisbon 2267057, 1649-028
    Portugal

    Site Not Available

  • Clinical Trial Site

    Porto, 4099-001
    Portugal

    Site Not Available

  • Clinical Trial Site

    Porto 2735943, 4099-001
    Portugal

    Site Not Available

  • Clinical Trial Site

    Bucharest, 011172
    Romania

    Site Not Available

  • Clinical Trial Site

    Bucharest 683506, 011172
    Romania

    Site Not Available

  • Clinical Trial Site

    Cluj-Napoca, 400000
    Romania

    Site Not Available

  • Clinical Trial Site

    Cluj-Napoca 681290, 400000
    Romania

    Site Not Available

  • Clinical Trial Site

    Timişoara, 300373
    Romania

    Site Not Available

  • Clinical Trial Site

    Belgrad, 11000
    Serbia

    Site Not Available

  • Clinical Trial Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Trial Site

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Clinical Trial Site

    Nové Mesto Nad Váhom, 91501
    Slovakia

    Site Not Available

  • Clinical Trial Site

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Clinical Trial Site

    Suwon 1835553, 16499
    South Korea

    Site Not Available

  • Clinical Trial Site

    Madrid, 28007
    Spain

    Site Not Available

  • Clinical Trial Site

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Clinical Trial Site

    Mataró, 8302
    Spain

    Site Not Available

  • Clinical Trial Site

    Kaohsiung, 833401
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Kaohsiung City 1673820, 833401
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Taichung, 40447
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Tainan, 710
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Tainan City 1668355, 710
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Clinical Trial Site

    Ankara, 06560
    Turkey

    Site Not Available

  • Clinical Trial Site

    Antalya, 07070
    Turkey

    Site Not Available

  • Clinical Trial Site

    Istanbul, 34096
    Turkey

    Site Not Available

  • Clinical Trial Site

    İzmir, 35210
    Turkey

    Site Not Available

  • Clinical Trial Site

    İzmit, 41380
    Turkey

    Site Not Available

  • Clinical Trial Site

    Ankara 323786, 06560
    Turkey (Türkiye)

    Site Not Available

  • Clinical Trial Site

    Antalya 323777, 07070
    Turkey (Türkiye)

    Site Not Available

  • Clinical Trial Site

    Istanbul 745044, 34096
    Turkey (Türkiye)

    Site Not Available

  • Clinical Trial Site

    Izmir 311046, 35210
    Turkey (Türkiye)

    Site Not Available

  • Clinical Trial Site

    İzmit 745028, 41380
    Turkey (Türkiye)

    Site Not Available

  • Clinical Trial Site

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Bath 2656173, BA1 3NG
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester, M13 9PT
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Manchester 2643123, M13 9PT
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Wolverhampton 2633691, WV10 0QP
    United Kingdom

    Site Not Available

  • Clinical Trial Site

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Clinical Trial Site

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Clinical Trial Site

    Phoenix 5308655, Arizona 5551752 85028
    United States

    Site Not Available

  • Clinical Trial Site

    Scottsdale 5313457, Arizona 5551752 85259
    United States

    Site Not Available

  • Clinical Trial Site

    Irvine, California 92617
    United States

    Site Not Available

  • Clinical Trial Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Clinical Trial Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Clinical Trial Site

    Irvine 5359777, California 5332921 92617
    United States

    Site Not Available

  • Clinical Trial Site

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Clinical Trial Site

    San Francisco 5391959, California 5332921 94115
    United States

    Site Not Available

  • Clinical Trial Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Clinical Trial Site

    Denver, Colorado 80230
    United States

    Site Not Available

  • Clinical Trial Site

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Clinical Trial Site

    Denver 5419384, Colorado 5417618 80230
    United States

    Site Not Available

  • Clinical Trial Site

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Clinical Trial Site

    Gainesville, Florida 32606
    United States

    Site Not Available

  • Clinical Trial Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Clinical Trial Site

    Orlando, Florida 32827
    United States

    Site Not Available

  • Clinical Trial Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Clinical Trial Site

    Tampa, Florida 33613
    United States

    Site Not Available

  • Clinical Trial Site

    Boynton Beach 4148677, Florida 4155751 33472
    United States

    Site Not Available

  • Clinical Trial Site

    Gainesville 4156404, Florida 4155751 32606
    United States

    Site Not Available

  • Clinical Trial Site

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Clinical Trial Site

    Plantation 4168782, Florida 4155751 33324
    United States

    Site Not Available

  • Clinical Trial Site

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Clinical Trial Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Clinical Trial Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Clinical Trial Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Clinical Trial Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Clinical Trial Site

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • Clinical Trial Site

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Clinical Trial Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Clinical Trial Site

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Clinical Trial Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Clinical Trial Site

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Clinical Trial Site

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Clinical Trial Site

    New Orleans 4335045, Louisiana 4331987 70433
    United States

    Site Not Available

  • Clinical Trial Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Clinical Trial Site

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Site Not Available

  • Clinical Trial Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Clinical Trial Site

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Clinical Trial Site

    Ann Arbor, Michigan 48103
    United States

    Site Not Available

  • Clinical Trial Site

    Ann Arbor 4984247, Michigan 5001836 48103
    United States

    Site Not Available

  • Clinical Trial Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Clinical Trial Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Clinical Trial Site

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • Clinical Trial Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Clinical Trial Site

    Manhasset, New York 11030
    United States

    Site Not Available

  • Clinical Trial Site

    New York, New York 10021
    United States

    Site Not Available

  • Clinical Trial Site

    Manhasset 5125766, New York 5128638 11030
    United States

    Site Not Available

  • Clinical Trial Site

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Clinical Trial Site

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Clinical Trial Site

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Clinical Trial Site

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Clinical Trial Site

    Oklahoma City 4544349, Oklahoma 4544379 73116
    United States

    Site Not Available

  • Clinical Trial Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Clinical Trial Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Trial Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Clinical Trial Site

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Clinical Trial Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Clinical Trial Site

    Jackson 4632595, Tennessee 4662168 38305
    United States

    Site Not Available

  • Clinical Trial Site

    Austin, Texas 78756
    United States

    Site Not Available

  • Clinical Trial Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Clinical Trial Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Clinical Trial Site

    Irving, Texas 75039
    United States

    Site Not Available

  • Clinical Trial Site

    Austin 4671654, Texas 4736286 78756
    United States

    Site Not Available

  • Clinical Trial Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Clinical Trial Site

    Irving 4700168, Texas 4736286 75039
    United States

    Site Not Available

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