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Phase 3 nipocalimab trial in adults with moderate to severe Sjögren's disease
2024-513965-38-01Phase 3Authorised
- Sponsor
- Janssen Pharmaceutical
- Start
- Jun 2025
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Countries
- 24
01
Overview
Phase 3, randomised, double-blind trial in Sjögren's syndrome comparing Nipocalimab with Placebo comparator (2 arms). Primary endpoint: Change from baseline in Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index score at Week 48. Planned start Jun 2025; status: authorised.
02
Drugs
nipocalimab
03
Conditions
Sjögren's syndrome
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