Johnson & Johnson’s Nipocalimab Shows Promising Results in Phase 2 Lupus Study

Systemic lupus erythematosus (SLE) remains one of the most challenging autoimmune diseases to treat. Many patients continue to experience disease activity despite available therapies, increasing their risk of long-term organ damage and reduced quality of life.
Now, Johnson & Johnson has reported encouraging Phase 2 results for nipocalimab, an investigational therapy designed to target one of the key drivers of lupus. The findings come from the JASMINE study and suggest that the drug could become a new treatment option for adults living with moderate-to-severe SLE.
The results will be presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London.
What Is Nipocalimab?
Nipocalimab is an investigational medicine designed to block the neonatal Fc receptor (FcRn). This receptor helps recycle immunoglobulin G (IgG) antibodies in the body.
In lupus, harmful IgG autoantibodies attack healthy tissues and contribute to inflammation throughout the body. By blocking FcRn, nipocalimab reduces circulating disease-causing antibodies while preserving important immune functions.
This approach aims to address the underlying cause of disease activity rather than simply managing symptoms.
Phase 2 JASMINE Study Meets Primary Endpoint
The JASMINE trial is the first study to demonstrate the potential effectiveness of FcRn blockade in systemic lupus erythematosus.
The study enrolled 228 adults with active moderate-to-severe lupus who had not responded adequately to at least one standard treatment.
Participants received either:
• Nipocalimab 5 mg/kg
• Nipocalimab 15 mg/kg
• Placebo
All patients continued receiving background standard-of-care treatments throughout the study.
At Week 24, the study met its primary endpoint. A greater percentage of patients receiving nipocalimab 15 mg/kg achieved an SRI-4 response compared with those receiving placebo.
The SRI-4 measure is commonly used in lupus studies to evaluate overall disease improvement.
Stronger Results Seen in Autoantibody-Positive Patients
One of the most notable findings came from a predefined subgroup analysis.
Researchers observed stronger treatment responses among patients who tested positive for lupus-associated autoantibodies. This group represents roughly 80% of people living with lupus.
At Week 52:
• 58.2% of autoantibody-positive patients receiving nipocalimab achieved an SRI-4 response.
• Only 36.1% of patients receiving placebo achieved the same response.
Researchers also evaluated Lupus Low Disease Activity State (LLDAS), a treatment target that reflects better disease control over time.
Among autoantibody-positive patients:
• 38.9% of those receiving nipocalimab achieved LLDAS.
• 18.0% of those receiving placebo reached the same milestone.
These results suggest that nipocalimab may offer meaningful long-term disease control for many lupus patients.
Benefits Continued Through One Year
The study also showed that treatment benefits were maintained through 52 weeks.
By Week 52:
• 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4 response.
• 39.7% of placebo-treated patients achieved the same outcome.
For LLDAS:
• 37.5% of patients receiving nipocalimab reached low disease activity.
• 20.5% of placebo-treated patients achieved the same result.
These findings indicate that disease improvements remained consistent over time.
What Experts Are Saying
Dr. Richard Furie, Chief of the Division of Rheumatology at Northwell Health, described the results as encouraging.
According to Dr. Furie, the improvements observed across disease activity measures and the reductions in harmful autoantibodies support continued development of nipocalimab as a targeted treatment option for lupus.
He also noted that sustained disease control is particularly important because many lupus patients continue to experience ongoing symptoms and remain at risk of irreversible organ damage.
Johnson & Johnson Highlights the Potential of Targeted Treatment
Leonard Dragone, Disease Area Leader for Autoantibody and Rheumatology at Johnson & Johnson, said the company is particularly encouraged by the strong responses seen in autoantibody-positive patients.
He noted that the findings support the potential of nipocalimab as an immunoselective therapy designed to address the biological drivers behind lupus rather than simply controlling symptoms.
Safety Profile Remained Consistent
Safety remains a critical consideration for any new lupus treatment.
In the JASMINE study, nipocalimab demonstrated a safety profile consistent with previous clinical studies.
No new safety concerns were identified.
The most commonly reported side effects included:
• Nasopharyngitis
• Headache
• Urinary tract infection
• Nausea
Overall, the treatment was generally well tolerated.
Understanding Systemic Lupus Erythematosus
Systemic lupus erythematosus is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues and organs.
The disease can affect multiple parts of the body, including:
• Skin
• Joints
• Kidneys
• Heart
• Lungs
• Brain
Lupus affects women far more frequently than men and often develops between the ages of 15 and 44.
Patients commonly experience fatigue, joint pain, swelling, skin rashes and other symptoms that can significantly impact daily life.
Globally, lupus affects an estimated 3 to 5 million people, with SLE accounting for approximately 70% of all lupus cases.
What Happens Next?
The positive Phase 2 findings provide important support for the ongoing Phase 3 GARDENIA study, which is currently recruiting patients.
Earlier this year, the U.S. Food and Drug Administration granted Fast Track Designation to nipocalimab for the treatment of systemic lupus erythematosus.
If future studies confirm these results, nipocalimab could become a new targeted treatment option for patients living with moderate-to-severe lupus, particularly those with autoantibody-positive disease.
Final Thoughts
The Phase 2 JASMINE study marks an important step forward in lupus research. While additional data from Phase 3 studies will be needed, the results suggest that targeting FcRn may offer a new way to reduce disease activity and improve long-term disease control.
For patients who continue to struggle with active lupus despite current therapies, nipocalimab represents a promising investigational approach that could help address one of the underlying causes of the disease rather than simply managing its symptoms.

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