A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Last updated: July 17, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Myositis

Treatment

Nipocalimab

Placebo

Glucocorticoids

Clinical Study ID

NCT05379634
CR109210
2023-505314-20
2023-505314-20-00
2021-005202-98
80202135IIM2001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Disease classification criteria: Participant meets the diagnostic criteria ofprobable or definite idiopathic inflammatory myopathies (IIM) based on 2017 TheEuropean League Against Rheumatism (EULAR)/American College of Rheumatology (ACR)classification criteria for adult IIM at least 6 weeks prior to first administrationof the study intervention

  • If a participant is on regular or as needed treatment with low potency topicalglucocorticoids (GC) that are allowed in the study or topical tacrolimus (TAC) totreat skin lesions, the dose and frequency should be stable for greater than orequal to (>=) 4 weeks prior to first administration of the study intervention aswell 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 anddeacetylase [NuRD] complex), anti-transcription intermediary factor 1-Gamma (TIF1-Gamma), anti- nuclear matrix protein 2 (NXP-2), anti-small ubiquitin-likemodifier-1 activating enzyme; anti- antimelanoma differentiation-associated gene 5 (MDA-5) antibodies. Or immune-mediated necrotizing myopathy (IMNM): anti- signalrecognition particle (SRP) and anti- 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies. Or anti-synthetase syndrome (ASyS): anti- histidyl- ribonucleicacid [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 MSAis positive within different subtypes (defined by the central laboratory) atscreening, the tests should be repeated during the screening period. If the sameresults are observed at retesting, the participant should not be enrolled in thestudy

Exclusion

Exclusion Criteria:

  • Has a juvenile myositis diagnosis and now >=18 years old

  • Has cancer-associated myositis defined as cancer diagnosis within 3 years ofmyositis diagnosis except for cervical carcinoma in situ and non-melanoma skincancer (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 relatedto the treatment of the participants IIM

  • Has experienced myocardial infarction (MI), unstable ischemic heart disease, orstroke within 12 weeks of screening

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: Nipocalimab
Phase: 2
Study Start date:
July 05, 2022
Estimated Completion Date:
September 16, 2026

Connect with a study center

  • Lawson Health Research / London Health Sciences Center Research

    London, Ontario N6C 2R5
    Canada

    Site Not Available

  • AMIR Research

    Montreal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Revmatologicky ustav

    Praha 2, 128 50
    Czechia

    Site Not Available

  • Hospital Pasteur

    Nice Cedex 1, 06000
    France

    Site Not Available

  • CHU de Nice, Hopital de l'Archet

    Nice Cedex 3, 06200
    France

    Site Not Available

  • Hôpital Pitié-Salpétrière

    Paris, 75013
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098
    France

    Site Not Available

  • Nouvel Hopital Civil

    Strasbourg cedex, 67091
    France

    Site Not Available

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Charite Universitatsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Active - Recruiting

  • Klinikum der Universitaet Muenchen

    München, 80336
    Germany

    Site Not Available

  • Immanuel Klinik Rüdersdorf

    Rüdersdorf Bei Berlin, 15562
    Germany

    Site Not Available

  • Orszagos Mozgasszervi Intezet ORFI Campus

    Budapest, 1023
    Hungary

    Site Not Available

  • Országos Mozgásszervi Intézet ORFI telephely

    Budapest, 1023
    Hungary

    Active - Recruiting

  • Debreceni Egyetem

    Debrecen, 4032
    Hungary

    Site Not Available

  • A.O. Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele HSR

    Milano, 20132
    Italy

    Active - Recruiting

  • IRCSS Ospedale San Raffaele Turro

    Milano, 20127
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima, 960 1295
    Japan

    Site Not Available

  • St Marianna University Hospital

    Kanagawa, 216 8511
    Japan

    Site Not Available

  • St.Marianna University Hospital

    Kanagawa, 216-8511
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi Nagano, 586 8521
    Japan

    Site Not Available

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, 586-8521
    Japan

    Site Not Available

  • Chiba-Nishi General Hospital

    Matsudo-shi, 270-2251
    Japan

    Active - Recruiting

  • Tokushukai Chiba-Nishi General Hospital

    Matsudo-shi, 270-2251
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto, 390-8621
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-Shi, 980-8574
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Tokyo, 113 8603
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Tokyo, 104 8560
    Japan

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon-si, 16499
    Korea, Republic of

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Ciudad de Mexico, 14080
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

    Ciudad de Mexico, 14080
    Mexico

    Site Not Available

  • Centro Integral en Reumatologia S A de C V

    Guadalajara, 44160
    Mexico

    Site Not Available

  • Centro Integral en Reumatología S.A de C.V.

    Guadalajara, 44160
    Mexico

    Active - Recruiting

  • Centro de Estudios de Investigacion Basica y Clinica, S.C.

    Guadalajara, 44690
    Mexico

    Site Not Available

  • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V

    Mexico, 06700
    Mexico

    Site Not Available

  • CLIDITER S A de C V

    México, 06700
    Mexico

    Site Not Available

  • CLIDITER, S.A. de C.V.

    México, 06700
    Mexico

    Active - Recruiting

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 105 AZ
    Netherlands

    Site Not Available

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85 168
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warszawa, 02 637
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

    Warszawa, 02-637
    Poland

    Active - Recruiting

  • Hosp. Univ. De Bellvitge

    Barcelona, 08907
    Spain

    Active - Recruiting

  • Hosp. Univ. de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hosp. Univ. de La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • University College London Hospitals NHSFT

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Manchester, M6 8HD
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • HonorHealth Neurology

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Attune Health Autoimmune and Inflamation Care and Research

    Beverly Hills, California 90211
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • FM Clinical Research, LLC South Florida Neurology Associates, P. A.

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida 33324
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • The Brigham and Women's Hospital, Inc.

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Wexner Medical Center at the Ohio State University

    Columbus, Ohio 43203
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • ACME Research Arthritis and Osteoporosis Center

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Nervie and Muscle Center of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas at Houston Medical School

    Houston, Texas 77030
    United States

    Site Not Available

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