Johnson & Johnson reports positive Phase 2b JASMINE trial results for nipocalimab in systemic lupus erythematosus, showing SRI-4 response, steroid-sparing potential, and a supportive safety profile as the program moves into Phase 3.
Written By: Pharmacally Medical News Desk
Johnson & Johnson announced encouraging topline results from the Phase 2b JASMINE study evaluating nipocalimab in adults with systemic lupus erythematosus (SLE). The trial met its primary endpoint, showing a statistically significant improvement in the percentage of patients achieving Systemic Lupus Erythematosus Responder Index (SRI-4) response, a validated composite measure that evaluates improvement across multiple lupus disease activity scores at Week 24 compared with placebo.
The study also met key secondary and exploratory endpoints, including findings that support the potential for steroid-sparing benefits. Nipocalimab demonstrated a safety and tolerability profile consistent with prior Phase 2 studies, with no new safety signals observed. Based on these data, the company has initiated a Phase 3 development program.
Nipocalimab represents the first FcRn blocker to report positive results in SLE, a chronic autoimmune condition affecting an estimated 3 to 5 million people globally and approximately 450,000 people in the United States. SLE is marked by persistent inflammation and multi-organ involvement, often presenting with fatigue, joint pain, and the characteristic butterfly-shaped facial rash. Long-term dependence on steroids remains a major challenge, contributing to organ damage and reduced quality of life.
The Phase 2b JASMINE trial (NCT04882878) was a 52-week, multicenter, randomized, double-blind, placebo-controlled study enrolling 228 adults with active SLE. Investigators evaluated dose-ranging regimens of nipocalimab to assess reductions in disease activity, along with safety outcomes. Full data will be presented at an upcoming medical meeting.
Nipocalimab is an investigational monoclonal antibody designed to block the neonatal Fc receptor (FcRn). By reducing circulating IgG autoantibodies, the therapy aims to lower immune-mediated disease activity while preserving broader immune function.
Nipocalimab has also received multiple regulatory designations from the FDA and EMA across several autoantibody-driven conditions, reflecting its broad therapeutic potential. These include Orphan Drug and Fast Track designations in indications such as Hemolytic Disease of the Fetus and Newborn (HDFN), Warm Autoimmune Hemolytic Anemia (wAIHA), and Generalized Myasthenia Gravis (gMG), Breakthrough Therapy designations in HDFN and Sjögren’s disease, and Priority Review for gGM. The EMA has additionally granted orphan status in select maternal-fetal alloimmune disorders.
SLE continues to pose significant unmet need despite advances in targeted biologics. Leonard L. Dragone, Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson Innovative Medicine highlighted the burden of steroid-related complications and emphasized the promise of immunoselective strategies such as FcRn blockade. If confirmed in Phase 3, nipocalimab may represent a new therapeutic pathway aimed at reducing disease activity while limiting long-term treatment toxicity.
Reference
Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study, 06 January 2026, Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study
A Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus, ClinicalTrials.gov ID NCT04882878, https://www.clinicaltrials.gov/study/NCT04882878