A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

NCT05379634 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: CR10921080202135IIM20012023-505314-20-00
• Study Type: interventional
• Target: 36
• Locations: 13 countries
• Sites: 57

Brief 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).

Conditions

Myositis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  At Week 52

Secondary Outcomes (28)

• Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS

  At Week 24

• IMACS TIS

  At Week 52

• Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS

  At Week 24

• Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52

  Baseline and Week 52

• IMACS TIS

  At Week 24

Study Arms (2)

Nipocalimab

EXPERIMENTAL

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.

Drug: Nipocalimab; Drug: Glucocorticoids

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo; Drug: Glucocorticoids

Interventions

Nipocalimab DRUG

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

Also known as: JNJ-80202135, JNJ-86507083

Nipocalimab

Glucocorticoids DRUG

Prednisone or equivalent will be administered orally as Glucocorticoid.

Nipocalimab; Placebo

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (57)

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, 85032, United States

Location

HonorHealth Neurology

Scottsdale, Arizona, 85251, United States

Location

Attune Health Autoimmune and Inflamation Care and Research

Beverly Hills, California, 90211, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

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

Boca Raton, Florida, 33487, United States

Location

Integral Rheumatology And Immunology Specialists

Plantation, Florida, 33324, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, 02115, United States

Location

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, 48081, United States

Location

Wexner Medical Center at the Ohio State University

Columbus, Ohio, 43203, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

ACME Research Arthritis and Osteoporosis Center

Orangeburg, South Carolina, 29118, United States

Location

Nervie and Muscle Center of Texas

Houston, Texas, 77030, United States

Location

University of Texas at Houston Medical School

Houston, Texas, 77030, United States

Location

Lawson Health Research / London Health Sciences Center Research

London, Ontario, N6C 2R5, Canada

Location

AMIR Research

Montreal, Quebec, H4A 3T2, Canada

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Hospital Pasteur

Nice, 06000, France

Location

Hôpital Pitié-Salpétrière

Paris, 75013, France

Location

Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Charite Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Klinikum der Universitaet Muenchen

München, 80336, Germany

Location

Immanuel Klinik Rüdersdorf

Rüdersdorf Bei Berlin, 15562, Germany

Location

Orszagos Mozgasszervi Intezet ORFI Campus

Budapest, 1023, Hungary

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, 60126, Italy

Location

IRCSS Ospedale San Raffaele Turro

Milan, 20127, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168, Italy

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960 1295, Japan

Location

St Marianna University Hospital

Kanagawa, 216 8511, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, 586 8521, Japan

Location

Tokushukai Chiba-Nishi General Hospital

Matsudo-shi, 270-2251, Japan

Location

Shinshu University Hospital

Matsumoto, 390-8621, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

St. Luke's International Hospital

Tokyo, 104 8560, Japan

Location

Nippon Medical School Hospital

Tokyo, 113 8603, Japan

Location

Centro Integral en Reumatologia S A de C V

Guadalajara, 44160, Mexico

Location

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

Guadalajara, 44690, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

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

México, 06700, Mexico

Location

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85 168, Poland

Location

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

Warsaw, 02 637, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Hosp. Univ. de Bellvitge

Barcelona, 08907, Spain

Location

Hosp. Univ. de La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

University College London Hospitals NHSFT

London, WC1N 3BG, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Myositis

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 18, 2022
• Study Start: July 5, 2022
• Primary Completion: September 4, 2025
• Study Completion (Estimated): September 16, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

HU (2); KR (2); IT (4); ME (4); US (19); PL (2); DE (3); GB (3); CZ (1); ES (3); JP (9); CA (2); FR (3)