Nipocalimab Delivers Positive Phase IIb Results in JASMINE SLE Trial

Johnson & Johnson has shared positive results from the Phase IIb JASMINE clinical trial (NCT04882878) evaluating nipocalimab in adults living with systemic lupus erythematosus (SLE).¹

JASMINE study demonstrates positive treatment response

At 24 weeks, JASMINE met its primary endpoint of percentage of patients achieving Systemic Lupus Erythematosus Responder Index (SRI-4) compared with placebo.

• The study also met key secondary and exploratory endpoints, including those assessing nipocalimab’s potential for steroid sparing.
• Nipocalimab’s safety and tolerability profile in JASMINE was consistent with previous Phase II studies evaluating the monoclonal antibody, with no new signals identified.

In a press release, Leonard L Dragone, MD, PhD, disease area leader, autoantibody and rheumatology, Johnson & Johnson Innovative Medicine, said: “Systemic lupus erythematosus or SLE is a serious autoantibody-driven disease that can impact multiple organ systems, significantly reducing health-related quality of life for millions of people. 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.”

Positive data mark first encouraging results of an FcRn blocker in SLE

According to J&J, this readout from JASMINE represents the first positive trial results of an investigational FcRn blocker treatment in SLE. Symptoms of the chronic, autoantibody disease include joint pain and swelling, rashes, and severe fatigue. An estimated 3 to 5 million people worldwide are impacted by SLE, including 450,000 in the US.

JASMINE study design

JASMINE is a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

• The trial is evaluating dose-ranging regimens of nipocalimab.
• A total of 228 participants were enrolled and randomized.

J&J plans on sharing the full results from JASMINE at a future medical conference.

Nipocalimab approved by FDA in 2025 for gMG

Earlier in April 2025, the FDA approved nipocalimab as IMAAVY for the treatment of generalized myasthenia gravis (gMG).²

Following Priority Review designation, the approval marked a new treatment option for adults and pediatric patients 12 years of age and older with gMG who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.

Approval based on positive Vivacity-MG3 results

The approval was based on data from the Phase III Vivacity-MG3 study (NCT04951622), which showed that patients who received nipocalimab plus standard of care saw an improvement of 4.70 points in activities of daily living (MG-ADL) score over 24 weeks—significantly higher than the 3.25-point increase demonstrated by placebo plus SOC.

In a press release from the time of the approval, Nicholas J. Silvestri, MD, professor of neurology at University of Buffalo, said: “The clinical results we’ve seen with IMAAVY represent a significant milestone in the treatment of gMG. 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.”

Vivacity-MG3 trial design

Vivacity-MG3 is a randomized, double-blind, placebo-controlled study.

• The trial enrolled 199 patients, including 153 antibody-positive individuals, and followed participants for 24 weeks.
• Patients were randomized 1:1 to nipocalimab plus standard of care or placebo plus standard of care.
• Nipocalimab dosing included a 30 mg/kg IV loading dose followed by 15 mg/kg every two weeks.
• The primary endpoint was mean change in MG-ADL score over Weeks 22-24 in antibody-positive patients.

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. Accessed 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. FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis. Applied Clinical Trials. April 30, 2025. Accessed January 6, 2026. https://www.appliedclinicaltrialsonline.com/view/fda-approves-nipocalimab--treatment-generalized-myasthenia-gravis