A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
NCT ID: NCT05379634
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2022-07-05
2026-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nipocalimab
Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106.
Nipocalimab
Nipocalimab will be administered intravenously in double-blind period and LTE period.
Glucocorticoids
Prednisone or equivalent will be administered orally as Glucocorticoid.
Placebo
Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.
Placebo
Nipocalimab matching placebo will be administered intravenously in double-blind period.
Glucocorticoids
Prednisone or equivalent will be administered orally as Glucocorticoid.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
AMIR Research
Montreal, Quebec, Canada
Revmatologicky ustav
Prague, , Czechia
Hospital Pasteur
Nice, , France
Hôpital Pitié-Salpétrière
Paris, , France
Nouvel Hopital Civil
Strasbourg, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Klinikum der Universitaet Muenchen
München, , Germany
Immanuel Klinik Rüdersdorf
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
Tohoku University Hospital
Sendai, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Centro Integral en Reumatologia S A de C V
Guadalajara, , Mexico
Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
México, , Mexico
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hosp. Univ. de Bellvitge
Barcelona, , Spain
Hosp. Univ. de La Paz
Madrid, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Western General Hospital
Edinburgh, , United Kingdom
University College London Hospitals NHSFT
London, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
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Other Identifiers
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80202135IIM2001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505314-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109210
Identifier Type: -
Identifier Source: org_study_id