Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial enrolled approximately 4,019 people in total — around 2,009 in the placebo group and 2,010 in the belimumab (10 mg/kg) group. The trial was measuring the number of deaths, serious medical events (called serious adverse events, or SAEs — meaning unplanned medical occurrences serious enough to cause hospitalisation, be life-threatening, or cause lasting harm), and a set of specific health events the researchers had nominated to watch closely (such as serious infections, certain cancers, mood-related events, and severe reactions to the infusion). These were tracked mainly over the first 52 weeks while participants were actively receiving their assigned treatment. The reported data shows that during the active treatment period (up to Week 52), 8 deaths were recorded in the placebo group and 10 in the belimumab group. Serious adverse events were reported by 222 participants in the placebo group and 220 in the belimumab group. For the closely watched specific events, the reported data shows: serious infections occurred in 82 placebo and 75 belimumab participants; other infections of interest in 50 versus 36; non-melanoma skin cancers in 5 versus 5; other cancers in 3 versus 4; serious mood or psychiatric events in 1 versus 7; and serious infusion or hypersensitivity reactions in 23 versus 28. When a broader counting window was used — covering the full study follow-up period including time after treatment stopped — the reported data shows 22 deaths in the placebo group and 13 in the belimumab group, and SAEs in 241 versus 233 participants respectively. The numbers for the specific watched events were broadly similar to the on-treatment figures. These figures describe what was counted and recorded; they do not on their own tell us why differences occurred or what caused them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38279368) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Lupus Trial, Completed
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 have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) based on recognised medical guidelines.
- Your lupus is currently active (meaning you are experiencing symptoms or flares).
- Your blood tests show certain antibodies linked to lupus (confirm with trial site).
- You are currently on a stable treatment plan for lupus, which may include steroids (such as prednisone), antimalarial drugs (such as hydroxychloroquine), and/or immune-suppressing medications (such as azathioprine, methotrexate, or mycophenolate).
Who may not be able to join:
- You are currently pregnant or breastfeeding.
- You have previously been treated with belimumab, or have received a therapy that targets B cells (such as rituximab) in the past year, or have received certain other biological treatments (such as adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
- You have received a live vaccine in the past 30 days.
- You have severe, active lupus that is affecting your kidneys.
- You have severe, active lupus that is affecting your brain or nervous system.
- You currently have, or have previously tested positive for, HIV, hepatitis B, or hepatitis C.
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: GSK Clinical Trials, GlaxoSmithKline
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Deaths - On Treatment Period (Week 52); Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52); Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.