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New pill could tame rare Muscle-Skin disease

NCT ID NCT05437263

Disease control Sponsor: Priovant Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This phase 3 trial tests an oral drug called brepocitinib in 241 adults with dermatomyositis, a rare disease causing muscle weakness and skin rash. Participants receive either the drug or a placebo for 52 weeks to see if it improves symptoms. The study is active but no longer recruiting new participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Brepocitinib (an oral drug that targets inflammation)
What this could lead to
If successful, this could provide a new daily pill to control dermatomyositis symptoms and reduce reliance on steroids.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not work better than placebo, and side effects from immune suppression are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

241 people

The number who actually took part.

Started

Oct 2022

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for 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/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 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 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

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Conditions

The condition(s) this trial relates to.

dermatomyositis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatomyositis

Contacts and locations

Locations

  • Clinical Trial Site

    Phoenix, Arizona, 85028, United States

  • Clinical Trial Site

    Scottsdale, Arizona, 85258, United States

  • Clinical Trial Site

    Scottsdale, Arizona, 85259, United States

  • Clinical Trial Site

    Irvine, California, 92617, United States

  • Clinical Trial Site

    Los Angeles, California, 90095, United States

  • Clinical Trial Site

    San Francisco, California, 94115, United States

  • Clinical Trial Site

    Aurora, Colorado, 80045, United States

  • Clinical Trial Site

    Denver, Colorado, 80230, United States

  • Clinical Trial Site

    Boynton Beach, Florida, 33472, United States

  • Clinical Trial Site

    Gainesville, Florida, 32606, United States

  • Clinical Trial Site

    Jacksonville, Florida, 32224, United States

  • Clinical Trial Site

    Plantation, Florida, 33324, United States

  • Clinical Trial Site

    Tampa, Florida, 33613, United States

  • Clinical Trial Site

    Atlanta, Georgia, 30322, United States

  • Clinical Trial Site

    Augusta, Georgia, 30912, United States

  • Clinical Trial Site

    Marietta, Georgia, 30060, United States

  • Clinical Trial Site

    Chicago, Illinois, 60637, United States

  • Clinical Trial Site

    Iowa City, Iowa, 52242, United States

  • Clinical Trial Site

    Kansas City, Kansas, 66160, United States

  • Clinical Trial Site

    New Orleans, Louisiana, 70112, United States

  • Clinical Trial Site

    New Orleans, Louisiana, 70433, United States

  • Clinical Trial Site

    Baltimore, Maryland, 21224, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02115, United States

  • Clinical Trial Site

    Ann Arbor, Michigan, 48103, United States

  • Clinical Trial Site

    Minneapolis, Minnesota, 55455, United States

  • Clinical Trial Site

    Rochester, Minnesota, 55905, United States

  • Clinical Trial Site

    Manhasset, New York, 11030, United States

  • Clinical Trial Site

    New York, New York, 10017, United States

  • Clinical Trial Site

    New York, New York, 10021, United States

  • Clinical Trial Site

    Cincinnati, Ohio, 45267, United States

  • Clinical Trial Site

    Cleveland, Ohio, 44195, United States

  • Clinical Trial Site

    Oklahoma City, Oklahoma, 73116, United States

  • Clinical Trial Site

    Portland, Oregon, 97239, United States

  • Clinical Trial Site

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Trial Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Clinical Trial Site

    Jackson, Tennessee, 38305, United States

  • Clinical Trial Site

    Austin, Texas, 78756, United States

  • Clinical Trial Site

    Houston, Texas, 77030, United States

  • Clinical Trial Site

    Irving, Texas, 75039, United States

  • Clinical Trial Site

    Quilmes, Buenos Aires, B1878DVB, Argentina

  • Clinical Trial Site

    Caba, Buenos Aires F.D., 1425, Argentina

  • Clinical Trial Site

    Mendoza, 5519, Argentina

  • Clinical Trial Site

    Leuven, 3000, Belgium

  • Clinical Trial Site

    Plovdiv, 4000, Bulgaria

  • Clinical Trial Site

    Plovdiv, 4001, Bulgaria

  • Clinical Trial Site

    Plovdiv, 4004, Bulgaria

  • Clinical Trial Site

    Sofia, 1407, Bulgaria

  • Clinical Trial Site

    Vancouver, British Colombia, V5Y1K2, Canada

  • Clinical Trial Site

    Newmarket, Ontario, L3Y 5G8, Canada

  • Clinical Trial Site

    Concepción, Biobio, 4070280, Chile

  • Clinical Trial Site

    Recoleta, 8420383, Chile

  • Clinical Trial Site

    Santiago, 7640881, Chile

  • Clinical Trial Site

    Santiago, 8331150, Chile

  • Clinical Trial Site

    Temuco, 4800827, Chile

  • Clinical Trial Site

    Prague, 128 00, Czechia

  • Clinical Trial Site

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Clinical Trial Site

    Berlin, 10117, Germany

  • Clinical Trial Site

    Berlin, 15562, Germany

  • Clinical Trial Site

    Dresden, 01307, Germany

  • Clinical Trial Site

    Essen, 45147, Germany

  • Clinical Trial Site

    Freiburg im Breisgau, 79106, Germany

  • Clinical Trial Site

    Debrecen, 4032, Hungary

  • Clinical Trial Site

    Pécs, 7632, Hungary

  • Clinical Trial Site

    Szeged, 6720, Hungary

  • Clinical Trial Site

    Ashkelon, 7830604, Israel

  • Clinical Trial Site

    Haifa, 3109601, Israel

  • Clinical Trial Site

    Poria – Neve Oved, 1528001, Israel

  • Clinical Trial Site

    Tel Aviv, 6423906, Israel

  • Clinical Trial Site

    Tel Litwinsky, 52621, Israel

  • Clinical Trial Site

    Bari, 70126, Italy

  • Clinical Trial Site

    Pavia, 27100, Italy

  • Clinical Trial Site

    Roma, 00168, Italy

  • Clinical Trial Site

    Torino, 10126, Italy

  • Clinical Trial Site

    Monterrey, Nuevo León, 64718, Mexico

  • Clinical Trial Site

    Mérida, Yucatán, 97070, Mexico

  • Clinical Trial Site

    Guadalajara, 44690, Mexico

  • Clinical Trial Site

    Mexico City, 06700, Mexico

  • Clinical Trial Site

    San Luis Potosí City, 78290, Mexico

  • Clinical Trial Site

    Nijmegen, Gelderland, 6500 HB, Netherlands

  • Clinical Trial Site

    Amsterdam, 1105 AZ, Netherlands

  • Clinical Trial Site

    Bialystok, Podlaskie Voivodeship, 15-704, Poland

  • Clinical Trial Site

    Krakow, 30-363, Poland

  • Clinical Trial Site

    Lublin, 20-400, Poland

  • Clinical Trial Site

    Lublin, 20-607, Poland

  • Clinical Trial Site

    Nowa Sól, 67-100, Poland

  • Clinical Trial Site

    Poznan, 61-293, Poland

  • Clinical Trial Site

    Warsaw, 02-637, Poland

  • Clinical Trial Site

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

  • Clinical Trial Site

    Guimarães, 4835-044, Portugal

  • Clinical Trial Site

    Lisbon, 1649-028, Portugal

  • Clinical Trial Site

    Porto, 4099-001, Portugal

  • Clinical Trial Site

    Bucharest, 011172, Romania

  • Clinical Trial Site

    Cluj-Napoca, 400000, Romania

  • Clinical Trial Site

    Belgrade, 11000, Serbia

  • Clinical Trial Site

    Seoul, 03080, South Korea

  • Clinical Trial Site

    Suwon, 16499, South Korea

  • Clinical Trial Site

    Madrid, 28007, Spain

  • Clinical Trial Site

    Kaohsiung City, 833401, Taiwan

  • Clinical Trial Site

    Taichung, 40447, Taiwan

  • Clinical Trial Site

    Tainan, 710, Taiwan

  • Clinical Trial Site

    Taipei, 10002, Taiwan

  • Clinical Trial Site

    Ankara, 06560, Turkey (Türkiye)

  • Clinical Trial Site

    Antalya, 07070, Turkey (Türkiye)

  • Clinical Trial Site

    Istanbul, 34096, Turkey (Türkiye)

  • Clinical Trial Site

    Izmir, 35210, Turkey (Türkiye)

  • Clinical Trial Site

    İzmit, 41380, Turkey (Türkiye)

  • Clinical Trial Site

    Bath, BA1 3NG, United Kingdom

  • Clinical Trial Site

    Manchester, M13 9PT, United Kingdom

  • Clinical Trial Site

    Wolverhampton, WV10 0QP, United Kingdom

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