Efficacy and Safety Study of Nipocalimab for Adults with Active Inflammatory Myopathies

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 - Efficacy and Safety Study of Nipocalimab for Adults with IIM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005202-98-CZ

Enrollment

200

Registered

2022-08-16

Start date

2022-11-10

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Idiopathic Inflammatory Myopathies (IIM) MedDRA version: 20.0 Level: HLT Classification code 10028640 Term: Myopathies System Organ Class: 100000004859

Interventions

Product Name: Nipocalimab Product Code: M281/JNJ-80202135 Pharmaceutical Form: Solution for infusion INN or Proposed INN: nipocalimab CAS Number: 2211985-36-1 Current Sponsor code: JNJ-80202135 Other

Eligibility

Sex/Gender

All

Inclusion criteria

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-serious adverse event (SAE); 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 (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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 128 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of nipocalimab vs placebo in participants with active IIM.;Secondary Objective: - To further evaluate the efficacy of nipocalimab vs placebo across a range of outcome measures in participants with active IIM. - To evaluate the efficacy of nipocalimab vs placebo in oral GC reduction in participants with active IIM. - To evaluate the efficacy of nipocalimab vs placebo in disease activity improvement over time in participants with active IIM. - To evaluate the safety and tolerability of nipocalimab vs placebo in participants with active IIM - To evaluate the impact of nipocalimab on PROs in participants with active IIM. - To evaluate the PK and immunogenicity of nipocalimab in participants with active IIM. - DM participants only: To evaluate the efficacy of nipocalimab vs placebo in cutaneous disease activity improvement in participants with active IIM. ;Primary end point(s): Percentage of participants who achieve at least minimal improvement (=20) in IMACS TIS (International myositis assessment and clinical studies total improvement score) and on =5 mg/day of oral prednisone (or equivalent) from week 44 through week 52. ;Timepoint(s) of evaluation of this end point: At Week 52	—

Measure

Time frame

Main Objective: To evaluate the efficacy of nipocalimab vs placebo in participants with active IIM.;Secondary Objective: - To further evaluate the efficacy of nipocalimab vs placebo across a range of outcome measures in participants with active IIM. - To evaluate the efficacy of nipocalimab vs placebo in oral GC reduction in participants with active IIM. - To evaluate the efficacy of nipocalimab vs placebo in disease activity improvement over time in participants with active IIM. - To evaluate the safety and tolerability of nipocalimab vs placebo in participants with active IIM - To evaluate the impact of nipocalimab on PROs in participants with active IIM. - To evaluate the PK and immunogenicity of nipocalimab in participants with active IIM. - DM participants only: To evaluate the efficacy of nipocalimab vs placebo in cutaneous disease activity improvement in participants with active IIM. ;Primary end point(s): Percentage of participants who achieve at least minimal improvement (=20) in IMACS TIS (International myositis assessment and clinical studies total improvement score) and on =5 mg/day of oral prednisone (or equivalent) from week 44 through week 52. ;Timepoint(s) of evaluation of this end point: At Week 52

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Secondary

Measure	Time frame
Secondary end point(s): Key Secondary Endpoints: - 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. - Percentage of Participants who Achieve Oral GC Reduction to 5 mg/day of Oral Prednisone (or Equivalent) at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >5 mg/day at Baseline. - Percentage of Participants who Achieve at Least Minimal Improvement (=20) in IMACS TIS from Week 44 Through Week 52 and on =5 mg/day of Oral Prednisone (or Equivalent) from Week 44 Through Week 52. - Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function (PF-20) at Week 52 Other Secondary Endpoints: - IMACS TIS at Week 24 - Percentage of Participants who Achieve at Least Moderate Improvement (=40) in IMACS TIS at Week 52. - Percentage of Participants who Achieve at Least Major Improvement (=60) in IMACS TIS at Weeks 24 and 52. - Change from Baseline in MMT-8 at Week 24 - Change from Baseline in Physician Global Assessment (PhGA) at Weeks 24 and 52 - Change from Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool (MDAAT) at Weeks 24 and 52 - Change from Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52 - Percentage of Participants on =5 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 and Achieve oral GC Reduction to 5 mg/day at Week 44 and Maintain that Reduction Through Week 52, Among Participants on Oral GC >5mg/day at Baseline - Percentage of Participants who Achieve at Least Minimal Improvement (=20) in IMACS TIS From Week 44 Through Week 52 and on =7.5 mg/day of Oral Prednisone (or Equivalent) From Week 44	—

Measure

Time frame

Secondary end point(s): Key Secondary Endpoints: - 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. - Percentage of Participants who Achieve Oral GC Reduction to 5 mg/day of Oral Prednisone (or Equivalent) at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >5 mg/day at Baseline. - Percentage of Participants who Achieve at Least Minimal Improvement (=20) in IMACS TIS from Week 44 Through Week 52 and on =5 mg/day of Oral Prednisone (or Equivalent) from Week 44 Through Week 52. - Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function (PF-20) at Week 52 Other Secondary Endpoints: - IMACS TIS at Week 24 - Percentage of Participants who Achieve at Least Moderate Improvement (=40) in IMACS TIS at Week 52. - Percentage of Participants who Achieve at Least Major Improvement (=60) in IMACS TIS at Weeks 24 and 52. - Change from Baseline in MMT-8 at Week 24 - Change from Baseline in Physician Global Assessment (PhGA) at Weeks 24 and 52 - Change from Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool (MDAAT) at Weeks 24 and 52 - Change from Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52 - Percentage of Participants on =5 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 and Achieve oral GC Reduction to 5 mg/day at Week 44 and Maintain that Reduction Through Week 52, Among Participants on Oral GC >5mg/day at Baseline - Percentage of Participants who Achieve at Least Minimal Improvement (=20) in IMACS TIS From Week 44 Through Week 52 and on =7.5 mg/day of Oral Prednisone (or Equivalent) From Week 44

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Countries

Australia, Canada, Czechia, Czech Republic, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+31(0)71524 2166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026