Johnson & Johnson (J&J) announced that its monoclonal antibody nipocalimab met its primary objective in the Phase II JASMINE study, reducing disease activity in adults with moderate to severe systemic lupus erythematosus.
The results were presented as the latest data at the 2026 European Union of Rheumatology Associations (EULAR) Congress in London and demonstrated sustained efficacy over 52 weeks.
Nipocalimab, which targets the neonatal Fc receptor (FcRn), aims to reduce levels of pathogenic immunoglobulin G (IgG) autoantibodies and their associated immune complexes, thereby reducing inflammation associated with systemic lupus erythematosus (SLE).
By selectively reducing the level of circulating IgG, including autoantibodies, it is possible to target disease-causing factors while maintaining the necessary immune responses.
The JASMINE study is considered the first to demonstrate the efficacy of FcRn inhibition in systemic lupus erythematosus and provides pharmacodynamic, biomarker and clinical data for further research.
The primary objective of the study was met at week 24: 53.5% of participants receiving nipocalimab 15 mg/kg in combination with background medical therapy achieved a SLE Response Index 4 (SRI-4) response, compared with 46.7% in the placebo group with background medical therapy.
Among patients positive for lupus-associated autoantibodies, the SRI-4 response increased to 58.2% versus 36.1%, and the achievement of low lupus disease activity state (LLDAS) was 38.9% versus 18.0% at week 52.
At week 52, 53.61 TP3T of patients receiving nipocalimab achieved a SRI-4 response, compared with 39.71 TP3T in the placebo group. LLDAS scores were 37.51 TP3T in the nipocalimab group versus 20.51 TP3T in the placebo group.
The observed safety profile was consistent with previous studies: headache, nasopharyngitis, urinary tract infections and nausea were reported in at least 10% patients.
Leonard Dragone, head of J&J's autoantibody and rheumatology business, said: "The JASMINE study results provide important new information about the potential of nipocalimab for adults with moderate to severe systemic lupus erythematosus, and we continue to advance this program.".
«"We are particularly encouraged by the results obtained in study participants who tested positive for autoantibodies. These data confirm the potential of nipocalimab as a targeted immunoselective agent designed to address the underlying causes of systemic lupus erythematosus.".
Nipocalimab has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of systemic lupus erythematosus (SLE). The Phase III GARDENIA trial is currently 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 studies evaluating the safety and efficacy of Icotyde (icotrokinra), a once-daily oral treatment for moderate to severe psoriasis.
The article "J&J's Nipocalimab Meets Primary Endpoint in Phase 2 JASMINE Study" was originally created and published by Clinical Trials Arena, a brand owned by GlobalData.
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