Phase 3 Lupus Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are in generally stable health based on a physical exam, medical history, vital signs, and heart tracing (ECG) done at the screening visit.
- You have been diagnosed with systemic lupus erythematosus (SLE/lupus) for at least 24 weeks before the screening visit, using recognised international classification guidelines.
- Your lupus disease activity must be above a certain level of severity, measured by specific scoring systems (SLEDAI-2K), both at the screening visit and at the start of the trial (Week 0) — the trial site can explain what scores are required.
- If you are someone who could become pregnant, you must have a negative pregnancy test (blood test at screening and urine test at the start of the trial).
- Your lupus must be affecting at least one body system severely, or two body systems moderately, as measured by another scoring tool called BILAG-2004 at screening.
Who may not be able to join:
- You have a serious, worsening, or uncontrolled condition affecting the liver, gut, kidneys, lungs, heart, mental health, nervous system, muscles/joints, or blood pressure, or any other uncontrolled autoimmune condition, or significantly abnormal blood test results at screening.
- Your lupus symptoms are unstable or getting worse in a way that would likely require stronger treatments than those allowed in the trial.
- You have a confirmed or suspected immune system deficiency that is not caused by your lupus treatment, or you have a close family history of an inherited immune deficiency (unless it has been confirmed that you do not have it).
- You have previously had a severe allergic reaction, such as anaphylaxis, to any biological or protein-based medicine.
- You have known or suspected allergies or sensitivities to the study drug (nipocalimab) or any of its ingredients, or to the ingredients in the placebo (dummy treatment).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Phone: 844-434-4210
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.