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ACTIVE NOT RECRUITING

NCT05379634

PHASE2

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-07-05

Completion Date

2026-09-16

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Myositis

Interventions

DRUG

Nipocalimab

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

OTHER

Placebo

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

DRUG

Glucocorticoids

Prednisone or equivalent will be administered orally as Glucocorticoid.

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

Locations (57)

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