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SPIREA: Phase 2 Study of Nipocalimab in Active Idiopathic Inflammatory Myopathies
jRCT2031220337Phase 2Active, not recruiting
- Sponsor
- Janssen Pharmaceutical
- Start
- Apr 2023
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
01
Overview
Phase 2, randomised, double-blind trial in Autoimmune Myopathies, dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and 1 more comparing Nipocalimab + glucocorticoids with Placebo + glucocorticoids (LTE switch to nipocalimab) (2 arms). Primary endpoint: IMACS TIS minimal improvement with low-dose prednisone at Week 52. Started Apr 2023; status: active, not recruiting.
02
Drugs
nipocalimab
03
Conditions
Autoimmune Myopathiesdermatomyositis (DM)immune-mediated necrotizing myopathy (IMNM)antisynthetase syndrome (ASSD)
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