A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
A legfontosabb adatok
- Hol
- Augusta, Baltimore, Beverly Hills, Boca Raton, Boston, Columbus, Houston, Kansas City, Orange, Orangeburg, Philadelphia, Phoenix, Plantation, Portland, Saint Clair Shores, Scottsdale, Tampa és Torrance (Egyesült Államok)Mind a 19 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Augusta UniversityAugusta, Egyesült ÁllamokNo longer taking part
- Johns Hopkins UniversityBaltimore, Egyesült ÁllamokNo longer taking part
- Attune Health Autoimmune and Inflamation Care and ResearchBeverly Hills, Egyesült ÁllamokNo longer taking part
- FM Clinical Research, LLC South Florida Neurology Associates, P. A.Boca Raton, Egyesült ÁllamokNo longer taking part
- The Brigham and Women's Hospital, Inc.Boston, Egyesült ÁllamokNo longer taking part
- Wexner Medical Center at the Ohio State UniversityColumbus, Egyesült ÁllamokNo longer taking part
- Nervie and Muscle Center of TexasHouston, Egyesült ÁllamokNo longer taking part
- University of Texas at Houston Medical SchoolHouston, Egyesült ÁllamokNo longer taking part
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
- University of California Irvine Medical CenterOrange, Egyesült ÁllamokNo longer taking part
- ACME Research Arthritis and Osteoporosis CenterOrangeburg, Egyesült ÁllamokNo longer taking part
- University of Pennsylvania Perelman School of MedicinePhiladelphia, Egyesült ÁllamokNo longer taking part
- Arizona Arthritis and Rheumatology Research PLLCPhoenix, Egyesült ÁllamokNo longer taking part
- Integral Rheumatology And Immunology SpecialistsPlantation, Egyesült ÁllamokNo longer taking part
- Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- Clinical Research Institute of Michigan, LLCSaint Clair Shores, Egyesült ÁllamokNo longer taking part
- HonorHealth NeurologyScottsdale, Egyesült ÁllamokNo longer taking part
- University of South FloridaTampa, Egyesült ÁllamokNo longer taking part
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Janssen Research & Development, LLC
- Azonosító
- NCT05379634EU 2023-505314-20-00
- A regiszteradat frissítve
- 2026. november 4.
- Eredeti leírás
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).A teljes eredeti leírásKevesebb
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
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
Bevonási feltételek: 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.
Kizáró feltételek: 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 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 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; Has a juvenile myositis diagnosis and now >=18 years old.