Johnson & Johnson (J&J) has reported that its monoclonal antibody, nipocalimab, met the primary endpoint in the Phase II JASMINE study by reducing disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE).
The results were presented as late-breaking data at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and showed sustained efficacy through 52 weeks.
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Nipocalimab, which targets the neonatal Fc receptor (FcRn), aims to reduce pathogenic immunoglobulin G (IgG) autoantibody levels and associated immune complexes, thereby reducing SLE-related inflammation.
By selectively decreasing circulating IgG, including autoantibodies, it may address disease drivers while maintaining essential immune responses.
The JASMINE study is said to be the first to demonstrate efficacy for FcRn inhibition in SLE, providing pharmacodynamic, biomarker, and clinical support for further investigations.
The study achieved its main goal at week 24: 53.5% of participants receiving nipocalimab 15mg/kg with background medication achieved an SLE Responder Index 4 (SRI-4) response, compared with 46.7% for placebo plus background medication.
Among those positive for lupus-related autoantibodies, SRI-4 response rose to 58.2% versus 36.1%, and achievement of Lupus Low Disease Activity State (LLDAS) was 38.9% versus 18.0% at week 52.
At week 52, 53.6% of patients receiving nipocalimab achieved an SRI-4 response, compared with 39.7% in the placebo group. LLDAS rates were 37.5% for the nipocalimab group versus 20.5% for placebo.
The safety profile observed was consistent with previous studies, with headache, nasopharyngitis, urinary tract infection and nausea reported in at least 10% of patients.
J&J autoantibody and rheumatology disease area leader Leonard Dragone said: “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 programme.
“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 has received fast track designation from the US Food and Drug Administration (FDA) for SLE. The Phase III GARDENIA study is enrolling participants.
In March 2026, J&J reported new 52-week data from the Phase III ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, and ICONIC-LEAD trials, evaluating the safety and efficacy of Icotyde (icotrokinra), a once-daily oral pill for moderate-to-severe plaque psoriasis.
