Nipocalimab Reduces Disease Activity in Moderate-to-Severe SLE in Phase 2 Trial

Johnson & Johnson announced nipocalimab met the primary endpoint of the Phase 2 JASMINE trial, significantly reducing disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE) through Week 52, according to a press release issued on June 3, 2026.¹

Nipocalimab is the first neonatal Fc receptor (FcRn) blocker investigated in SLE and represents a mechanistically distinct approach from approved agents. Results were presented as a late-breaking abstract at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London.¹

"The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus," Richard Furie, MD, Chief of the Division of Rheumatology at Northwell, said in a statement. "These 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage."

Existing approved therapies for SLE, including belimumab and anifrolumab, target B-cell survival or type I interferon signaling, respectively. The JASMINE results provide the first proof-of-concept data for FcRn blockade in this indication, adding to a mechanism already under late-phase investigation in conditions including generalized myasthenia gravis and warm autoimmune hemolytic anemia.¹

JASMINE was a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study enrolling 228 adults aged 18 to 65 years with active, moderate-to-severe SLE.¹

Eligible participants were positive for antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA), and/or anti-Smith antibodies and had not responded to at least one standard-of-care treatment. Participants were randomly assigned in a 1:1:1 ratio to intravenous nipocalimab 5 mg/kg, nipocalimab 15 mg/kg, or placebo every 2 weeks through week 52, each administered alongside protocol-permitted background medications.¹

The primary endpoint was the SLE Responder Index-4 (SRI-4) composite response at week 24. The SRI-4 integrates criteria from the SELENA-SLEDAI, Physician Global Assessment, and BILAG-2004 indices.

At week 24, nipocalimab 15 mg/kg achieved an SRI-4 response rate of 53.5% compared with 46.7% for placebo plus background medication, meeting the primary endpoint.¹

Results showed benefit was maintained at the key secondary endpoint of SRI-4 at week 52, where 53.6% of participants receiving nipocalimab 15 mg/kg achieved a response compared with 39.7% in the placebo group.¹

Nipocalimab 15 mg/kg also demonstrated greater achievement of Lupus Low Disease Activity State (LLDAS), a key exploratory endpoint supporting a treat-to-target approach, compared with placebo at week 52 (37.5% vs 20.5%). LLDAS achievement requires low disease activity on validated composite measures, a prednisolone dose no greater than 7.5 mg daily, and well-tolerated immunosuppressive therapy.¹

A predefined autoantibody-positive subgroup, which represented approximately 80% of the enrolled population, showed magnified treatment separation at week 52. SRI-4 response rates in this subgroup were 58.2% vs 36.1% and LLDAS achievement was 38.9% vs 18.0% for nipocalimab 15 mg/kg versus placebo, respectively.¹

The safety profile of nipocalimab was consistent with prior studies of the agent and no new signals were identified. The most common adverse reactions occurring in ≥ 10% of nipocalimab-treated participants were nasopharyngitis, headache, urinary tract infection, and nausea.¹

“The JASMINE results provide important new insights into the potential of nipocalimab for adults with moderate-to-severe systemic lupus erythematosus as we continue advancing this program,” Leonard Dragone, MD, PhD, Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson, said in a statement. “We are especially encouraged by the responses observed in autoantibody-positive study participants. These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus.”

Nipocalimab received FDA Fast Track designation in SLE in January 2026. The ongoing Phase 3 GARDENIA study is currently enrolling adults with SLE. Nipocalimab is also under investigation in rheumatoid arthritis, Sjögren's disease, generalized myasthenia gravis, warm autoimmune hemolytic anemia, and fetal/neonatal alloimmune conditions.^1,2

References

1. Johnson & Johnson. Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study. Published June 3, 2026. Accessed June 3, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-late-breaking-results-show-nipocalimab-significantly-reduced-systemic-lupus-erythematosus-sle-disease-activity-in-a-phase-2-study

2. ClinicalTrials.gov. NCT07438496 (GARDENIA). Available at: https://clinicaltrials.gov/study/NCT07438496. Accessed June 3, 2026.