Nipocalimab Reduces SLE Disease Activity, Meeting JASMINE Study End Point

Nipocalimab reduced disease activity in adults with systemic lupus erythematosus (SLE), meeting the primary end point of Systemic Lupus Erythematosus Responder Index [SRI-4] composite response in the phase 2b JASMINE (NCT04882878) study. The positive data have prompted Johnson & Johnson’s plans to initiate a phase 3 study to continue investigations.1

“… SLE is a serious autoantibody-driven disease that can impact multiple organ systems, significantly reducing health-related quality of life for millions of people,” Leonard L. Dragone, MD, PhD, Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson Innovative Medicine, said in a statement.1 “Many people living with SLE also face complications associated with long-term steroid use, underscoring the limitations of current treatment approaches and the critical need for immunoselective therapies that are safe, tolerable, and capable of reducing disease activity, while preserving immune function.”

JASMINE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study in 228 adults participants spanning 52 weeks. Its primary endpoint is SRI-4 composite response at Week 24 compared to placebo, and key secondary and exploratory endpoints include effects on steroid sparing. Investigators found that nipocalimab’s safety and tolerability profile was consistent with previous Phase 2 studies, and there were no new safety signals identified. Further data from JASMINE will be presented at a future medical conference.

Nipocalimab is a monoclonal antibody designed to block FcRn with high affinity and reduce levels of circulating immunoglobulin G (IgG) antibodies without affecting other adaptive and innate immune functions. It targets autoantibodies and alloantibodies involved in multiple conditions in the autoantibody space, including Rare Autoantibody diseases, maternal fetal diseases mediated by maternal alloantibodies, and autoantibody-driven rheumatic diseases.

Nipocalimab was approved in 2025, under the name Imaavy, to treat generalized myasthenia gravis (gMG) in adults and children (> 12 years) who are anti-acetylcholine receptor (AChR) or anti-muscular-specific kinase (MuSK) antibody positive.The therapy was approved in a 300 mg/ 1.62 mL formulation and a 1200 mg/6.5 mL (185 mg/mL) formulation of single-dose vials per carton for intravenous injection.2

"The clinical results we've seen with IMAAVY represent a significant milestone in the treatment of gMG," said Nicholas J. Silvestri, MD, professor of neurology at the University of Buffalo, in a statement at that time.2 "Patients experienced substantial symptom relief and lasting disease control that translated into better daily function and did not fade over 24 weeks in the pivotal Vivacity-MG3 study. Having a treatment that delivers this level of durable symptom stability is a meaningful step forward for managing a complex and unpredictable disease like gMG, and to have it in both AChR+ and MuSK+ adults and pediatric patients 12 years and older brings an additional FcRn treatment to a broader range of patients."

The FDA’s decision was supported by findings from the ongoing 24-week, double-blind, placebo-controlled phase 3 VIVACITY-MG3 trial.³ The study enrolled 199 adult patients with antibody-positive or antibody-negative generalized myasthenia gravis (gMG) who had shown an inadequate response to standard-of-care therapy. Participants were randomized 1:1 to receive either nipocalimab in combination with standard of care (a 30 mg/kg intravenous loading dose followed by 15 mg/kg every 2 weeks) or placebo plus standard of care.3

Results demonstrated that patients treated with nipocalimab achieved a 4.70-point improvement in the Myasthenia Gravis–Activities of Daily Living (MG-ADL) score, compared with a 3.35-point improvement in the placebo group over weeks 22, 23, and 24 (P = .002). Treatment with nipocalimab was also associated with significantly greater improvements in the Quantitative Myasthenia Gravis score versus placebo through weeks 22 and 24 (P <.001).3

References

1. 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. News release. Johnson & Johnson. January 6, 2026. https://www.jnj.com/media-center/press-releases/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

2. Derman C. FDA Approves Nipocalimab Generalized Myasthenia Gravis for Adults, Children. Article. HCPLive. April 30, 2025. https://www.hcplive.com/view/fda-approves-nipocalimab-generalized-myasthenia-gravis-for-adults-children

3. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. Johnson & Johnson. June 28, 2024. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class.