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
Frequently Asked Questions
What is nipocalimab being studied for in SLE?
Nipocalimab is an investigational FcRn blocker being evaluated for the treatment of moderate-to-severe SLE in adults. It is not FDA-approved for this indication; a phase 3 study is currently recruiting.
How does nipocalimab work?
Nipocalimab selectively blocks the neonatal Fc receptor (FcRn), reducing circulating pathogenic IgG autoantibodies and immune complexes implicated in SLE-associated inflammation, while preserving broader immune function.
What did the JASMINE trial show?
JASMINE met its primary endpoint: nipocalimab 15 mg/kg achieved an SRI-4 response rate of 53.5% versus 46.7% for placebo at week 24, with responses sustained through week 52 and amplified in autoantibody-positive participants.
"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
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
ClinicalTrials.gov. NCT07438496 (GARDENIA). Available at: https://clinicaltrials.gov/study/NCT07438496. Accessed June 3, 2026.
