GARDENIA

• Research type

  Research Study

• Full title

  A Phase 3, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

• IRAS ID

  1013215

• Contact name

  Elena Bolanos Cascales

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2025-523552-31

• Research summary

  Systemic lupus erythematosus (SLE) is a disease where the immune system attacks healthy tissues. Current treatments for SLE usually work by managing symptoms or suppressing the immune system. In this study, researchers want to learn how well the study drug (nipocalimab) works compared to placebo (dummy drug) in people with SLE aged 18-75 years old. Nipocalimab lowers the level of proteins in the blood called IgG (immunoglobulin G) thus reducing the body’s inflammatory immune response. The study comprises:
  • Screening period (6 weeks)
  • Double-blind treatment period (52 weeks): Participants will be assigned by chance to either nipocalimab or placebo
  • Open-label long-term extension period (104 weeks): Everyone receives nipocalimab
  • A safety follow-up visit 6 weeks after stopping treatment.
  There is no established benefit to participants. Taking nipocalimab may improve SLE but this cannot be guaranteed. Participants can continue standard of care SLE treatment and may benefit from frequent study visits and assessments monitoring their overall health.
  Participants may experience side effects from the drug or study procedures. These may be mild to severe or life-threatening and vary from person to person. The most common potential risks are infections, reduced effectiveness of vaccines, activation of latent virus, low levels of albumin (a blood protein), injection site reactions, allergic reactions, drug-drug interactions and increase in cholesterol. The participant information sheet lists in detail the potential risks to taking part in the study. Not all possible side effects and risks are known. The study sponsor may learn new information about nipocalimab. The study doctor will tell participants about new information that might make them change their mind about being in the study. To minimise the risk associated with taking part in the study, participants will be frequently reviewed for side effects/medical events & will receive appropriate medical care.

• REC name

  West of Scotland REC 1

• REC reference

  26/WS/0012

• Date of REC Opinion

  19 Feb 2026

• REC opinion

  Further Information Favourable Opinion