A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Myositis

In brief

The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).

Key facts

Study ID

NCT05379634

Run by

Janssen Research & Development, LLC

People needed

36

Starts

2022-07-05

Expected to finish

2026-09-16

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital Pasteur — Nice, France
• AMIR Research — Montreal, Quebec, Canada
• Arizona Arthritis and Rheumatology Research PLLC — Phoenix, Arizona, United States
• HonorHealth Neurology — Scottsdale, Arizona, United States
• Attune Health Autoimmune and Inflamation Care and Research — Beverly Hills, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• FM Clinical Research, LLC South Florida Neurology Associates, P. A. — Boca Raton, Florida, United States
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Augusta University — Augusta, Georgia, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• The Brigham and Women's Hospital, Inc. — Boston, Massachusetts, United States
• Clinical Research Institute of Michigan, LLC — Saint Clair Shores, Michigan, United States
• Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania - Perelman School of Medicine — Philadelphia, Pennsylvania, United States
• ACME Research Arthritis and Osteoporosis Center — Orangeburg, South Carolina, United States
• Nervie and Muscle Center of Texas — Houston, Texas, United States
• University of Texas at Houston Medical School — Houston, Texas, United States
• Lawson Health Research / London Health Sciences Center Research — London, Ontario, Canada
• Hopital Pitie Salpetriere — Paris, France
• Nouvel Hopital Civil — Strasbourg, France
• Revmatologicky ustav — Prague, Czechia

Full record on ClinicalTrials.gov

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