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Clinical Trials in the USA / NCT05379634
Active, not recruiting Phase 2

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

NCT05379634 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2022-07-05
Last updated
2026-06-05

Condition(s) studied

Myositis

Investigational drug(s) / intervention(s)

NipocalimabPlaceboGlucocorticoids

Nipocalimab: Nipocalimab will be administered intravenously in double-blind period and LTE period.

Placebo: Nipocalimab matching placebo will be administered intravenously in double-blind period.

Glucocorticoids: Prednisone or equivalent will be administered orally as Glucocorticoid.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (57)

FacilityCityRegionStatus
Arizona Arthritis and Rheumatology Research PLLC Phoenix Arizona
HonorHealth Neurology Scottsdale Arizona
Attune Health Autoimmune and Inflamation Care and Research Beverly Hills California
University of California Irvine Medical Center Orange California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
FM Clinical Research, LLC South Florida Neurology Associates, P. A. Boca Raton Florida
Integral Rheumatology And Immunology Specialists Plantation Florida
University of South Florida Tampa Florida
Augusta University Augusta Georgia
University of Kansas Medical Center Kansas City Kansas
Johns Hopkins University Baltimore Maryland
The Brigham and Women's Hospital, Inc. Boston Massachusetts
Clinical Research Institute of Michigan, LLC Saint Clair Shores Michigan
Wexner Medical Center at the Ohio State University Columbus Ohio
Oregon Health and Science University Portland Oregon
University of Pennsylvania - Perelman School of Medicine Philadelphia Pennsylvania
ACME Research Arthritis and Osteoporosis Center Orangeburg South Carolina
Nervie and Muscle Center of Texas Houston Texas
University of Texas at Houston Medical School Houston Texas
Lawson Health Research / London Health Sciences Center Research London Ontario
AMIR Research Montreal Quebec
Revmatologicky ustav Prague Czechia
Hospital Pasteur Nice France
Hopital Pitie Salpetriere Paris France
Nouvel Hopital Civil Strasbourg France
Charite Universitaetsmedizin Berlin Berlin Germany
Klinikum der Universitaet Muenchen München Germany
Immanuel Klinik Rudersdorf Rüdersdorf Bei Berlin Germany
Orszagos Mozgasszervi Intezet ORFI Campus Budapest Hungary
Debreceni Egyetem Debrecen Hungary
A.O. Universitaria Ospedali Riuniti di Ancona Ancona Italy
IRCSS Ospedale San Raffaele Turro Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Fondazione Policlinico Universitario A Gemelli IRCCS Roma Italy
National Hospital Organization Kyushu Medical Center Fukuoka Japan
Fukushima Medical University Hospital Fukushima Japan
St Marianna University Hospital Kanagawa Japan
National Hospital Organization Osaka Minami Medical Center Kawachi-Nagano Japan
Tokushukai Chiba-Nishi General Hospital Matsudo-shi Japan
Shinshu University Hospital Matsumoto Japan

+ 17 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05379634 on ClinicalTrials.gov ↗ ← All trials in the USA