A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
Key facts
- Where
- Augusta, Baltimore, Beverly Hills, Boca Raton, Boston, Columbus, Houston, Kansas City, Orange, Orangeburg, Philadelphia, Phoenix, Plantation, Portland, Saint Clair Shores, Scottsdale, Tampa, and Torrance, United StatesSee the 19 sites
- Phase
- Phase 2
Where in United States
- Augusta UniversityAugusta, United StatesNo longer taking part
- Johns Hopkins UniversityBaltimore, United StatesNo longer taking part
- Attune Health Autoimmune and Inflamation Care and ResearchBeverly Hills, United StatesNo longer taking part
- FM Clinical Research, LLC South Florida Neurology Associates, P. A.Boca Raton, United StatesNo longer taking part
- The Brigham and Women's Hospital, Inc.Boston, United StatesNo longer taking part
- Wexner Medical Center at the Ohio State UniversityColumbus, United StatesNo longer taking part
- Nervie and Muscle Center of TexasHouston, United StatesNo longer taking part
- University of Texas at Houston Medical SchoolHouston, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- University of California Irvine Medical CenterOrange, United StatesNo longer taking part
- ACME Research Arthritis and Osteoporosis CenterOrangeburg, United StatesNo longer taking part
- University of Pennsylvania Perelman School of MedicinePhiladelphia, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology Research PLLCPhoenix, United StatesNo longer taking part
- Integral Rheumatology And Immunology SpecialistsPlantation, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- Clinical Research Institute of Michigan, LLCSaint Clair Shores, United StatesNo longer taking part
- HonorHealth NeurologyScottsdale, United StatesNo longer taking part
- University of South FloridaTampa, United StatesNo longer taking part
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesNo longer taking part
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT05379634EU 2023-505314-20-00
- Record updated
- 4 November 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).Read full original descriptionShow less
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
Inclusion: 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: 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 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 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; Has a juvenile myositis diagnosis and now >=18 years old.