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New drug aims to tame muscle inflammation in myositis

NCT ID NCT05379634

Disease control Sponsor: Janssen Research & Development, LLC 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether nipocalimab, given intravenously, can improve symptoms of active idiopathic inflammatory myopathies (myositis) better than a placebo. About 36 adults with myositis will receive either nipocalimab or a placebo, along with standard steroid treatment. The main goal is to see if more people on nipocalimab achieve at least minimal improvement in muscle strength and daily function while using lower steroid doses.

What this could mean

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

Active substance
Nipocalimab (given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for myositis that helps control symptoms and reduces the need for steroids.
What could go wrong
This is a small, early-phase trial with only 36 participants. The drug may not prove more effective than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

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 years and older

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: * Disease classification criteria: Participant meets the diagnostic criteria of probable or definite idiopathic inflammatory myopathies (IIM) based on 2017 The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult IIM at least 6 weeks prior to first administration of the study intervention * If a participant is on regular or as needed treatment with low potency topical glucocorticoids (GC) that are allowed in the study or topical tacrolimus (TAC) to treat skin lesions, the dose and frequency should be stable for greater than or equal to (\>=) 4 weeks prior to first administration of the study intervention as well as maintained at the same dose until Week 52 of the study * Antibody positivity criteria: Any 1 of the myositis-specific antibodies (MSAs) positive: dermatomyositis (DM): anti-Mi-2 (Mi-2/nucleosome remodeling and deacetylase \[NuRD\] complex), anti-transcription intermediary factor 1-Gamma (TIF1-Gamma), anti- nuclear matrix protein 2 (NXP-2), anti-small ubiquitin-like modifier-1 activating enzyme; anti- antimelanoma differentiation-associated gene 5 (MDA-5) antibodies. Or immune-mediated necrotizing myopathy (IMNM): anti- signal recognition particle (SRP) and anti- 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies. Or anti-synthetase syndrome (ASyS): anti- histidyl- ribonucleic acid \[tRNA\] synthetase (Jo-1), anti- threonyl-tRNA synthetase (PL7), anti- alanyl-tRNA synthetase (PL12), anti- isoleucyl-tRNA synthetase (OJ), and anti- glycyl-tRNA synthetase (EJ) antibodies. If all MSAs are negative or more than 1 MSA is positive within different subtypes (defined by the central laboratory) at screening, the tests should be repeated during the screening period. If the same results are observed at retesting, the participant should not be enrolled in the study Exclusion Criteria: * Has a juvenile myositis diagnosis and now \>=18 years old * Has cancer-associated myositis defined as cancer diagnosis within 3 years of myositis diagnosis except for cervical carcinoma in situ and non-melanoma skin cancer (squamous cell carcinoma, basal cell carcinoma of the skin) * Has comorbidities (example, asthma, chronic obstructive pulmonary disease \[COPD\]) which have required 3 or more courses of oral GC within 1 year prior to screening * Has a history of primary immunodeficiency or secondary immunodeficiency not related to the treatment of the participants IIM * Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy juvenile dermatomyositis myositis disease

As listed by the trial registrant

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

Myositis

Contacts and locations

Locations

  • A.O. Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126, Italy

  • ACME Research Arthritis and Osteoporosis Center

    Orangeburg, South Carolina, 29118, United States

  • AMIR Research

    Montreal, Quebec, H4A 3T2, Canada

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona, 85032, United States

  • Attune Health Autoimmune and Inflamation Care and Research

    Beverly Hills, California, 90211, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V

    México, 06700, Mexico

  • Centro Integral en Reumatologia S A de C V

    Guadalajara, 44160, Mexico

  • Centro de Estudios de Investigacion Basica y Clinica, S.C.

    Guadalajara, 44690, Mexico

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081, United States

  • Debreceni Egyetem

    Debrecen, 4032, Hungary

  • FM Clinical Research, LLC South Florida Neurology Associates, P. A.

    Boca Raton, Florida, 33487, United States

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168, Italy

  • Fukushima Medical University Hospital

    Fukushima, 960 1295, Japan

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251, United States

  • Hopital Pitie Salpetriere

    Paris, 75013, France

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. de Bellvitge

    Barcelona, 08907, Spain

  • Hosp. Univ. de La Paz

    Madrid, 28046, Spain

  • Hospital Pasteur

    Nice, 06000, France

  • IRCSS Ospedale San Raffaele Turro

    Milan, 20127, Italy

  • Immanuel Klinik Rudersdorf

    Rüdersdorf Bei Berlin, 15562, Germany

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080, Mexico

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Klinikum der Universitaet Muenchen

    München, 80336, Germany

  • Lawson Health Research / London Health Sciences Center Research

    London, Ontario, N6C 2R5, Canada

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warsaw, 02 637, Poland

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563, Japan

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586 8521, Japan

  • Nervie and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • Nippon Medical School Hospital

    Tokyo, 113 8603, Japan

  • Nouvel Hopital Civil

    Strasbourg, 67091, France

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Orszagos Mozgasszervi Intezet ORFI Campus

    Budapest, 1023, Hungary

  • Revmatologicky ustav

    Prague, 128 50, Czechia

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shinshu University Hospital

    Matsumoto, 390-8621, Japan

  • St Marianna University Hospital

    Kanagawa, 216 8511, Japan

  • St. Luke's International Hospital

    Tokyo, 104 8560, Japan

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85 168, Poland

  • The Brigham and Women's Hospital, Inc.

    Boston, Massachusetts, 02115, United States

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Tokushukai Chiba-Nishi General Hospital

    Matsudo-shi, 270-2251, Japan

  • University College London Hospitals NHSFT

    London, WC1N 3BG, United Kingdom

  • University of California Irvine Medical Center

    Orange, California, 92868, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • University of Texas at Houston Medical School

    Houston, Texas, 77030, United States

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Wexner Medical Center at the Ohio State University

    Columbus, Ohio, 43203, United States

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Other studies related to the condition(s) this trial covers.