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)
Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 — At Week 52 Percentage of participants who achieve at least minimal improvement (\>=20) in IMACS TIS at Week 52 and on \<=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with idiopathic inflammatory myopathies (IIM). Minimal improvement is defined as IMACS TIS greater than or equal to (\>=) 20 in participants with IIM. The criteria use the 6 IMACS core set measures: physicians' global activity, patient global activity (PtGA), manual muscle testing (MMT)-8, muscle enzymes, myositis disease activity assessment tool (MDAAT), and health assessment questionnaire-disability index (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.
Trial sites (57)
Facility
City
Region
Status
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 UK
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.
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