A study of nipocalimab in participants with active idiopathic inflammatory myopathies
- Conditions
- Active idiopathic inflammatory myopathies (IIM)Musculoskeletal Diseases
- Registration Number
- ISRCTN98762360
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 200
1. 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
2. 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
3. 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
1. Has a juvenile myositis diagnosis and now =18 years old
2. 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)
3. Has comorbidities (for example, asthma, chronic obstructive pulmonary disease [COPD]) which have required three or more courses of oral GC within 1 year prior to screening
4. Has a history of primary immunodeficiency or secondary immunodeficiency not related to the treatment of the participants IIM
5. Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical improvement assessed as the percentage of participants who achieve at least minimal improvement (=20) in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) and on =5 mg/day of oral prednisone (or equivalent) from week 44 through week 52. This assessment is conducted at week 52.
- Secondary Outcome Measures
Name Time Method