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 looked at a medicine called belimumab (given at a dose of 10 mg/kg) compared to a placebo (a dummy treatment with no active ingredient) in people with a condition involving blood vessel inflammation known as vasculitis. A total of 105 people took part — 52 in the placebo group and 53 in the belimumab group. The trial was mainly measuring how long it took for participants to experience a "relapse," meaning a return or worsening of their condition. The reported data shows that for the primary outcome — time to first relapse — the result was recorded as "NA" (not available) for both groups. According to the trial's own explanation, this happened because too few relapses occurred during the study period to calculate a meaningful figure. For one of the secondary outcomes, the trial counted how many participants experienced a "major relapse" (defined as having at least one serious flare-up based on a specific scoring tool). The reported data shows that zero participants in the placebo group and one participant in the belimumab group had a major relapse during the double-blind phase of the study. It is also worth noting that, of those who started the trial, 12 people in the placebo group and 20 people in the belimumab group did not complete the study, though the reasons for this are not detailed in the data provided here. 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 30666823) ↗
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 3 Vasculitis 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 Wegener's granulomatosis (also called GPA) or microscopic polyangiitis using standard medical criteria.
- Your condition had a flare-up in the past 26 weeks that required treatment with high-dose steroids and one of the following medicines: rituximab, cyclophosphamide tablets, or cyclophosphamide given through a drip.
- You have previously tested positive for certain antibodies linked to these conditions (called anti-PR3 or anti-MPO antibodies) at any point before joining the trial.
- Your disease went into remission (became inactive) within 26 weeks of starting your treatment, meaning your disease activity score reached zero and you are taking less than 10mg per day of prednisone (or a similar steroid) on two check-up visits around a month apart.
- You are able to start the trial's maintenance treatment within 2 weeks of your remission being confirmed.
Who may not be able to join:
- You are currently pregnant or breastfeeding.
- You have ever received a B-cell targeting therapy other than rituximab (confirm with trial site).
- You have received an experimental biological medicine within the past 60 days.
- You have needed treatment for an active or ongoing infection in the past 60 days.
- You currently have a problem with drug or alcohol misuse or dependence.
- You have ever tested positive for HIV, hepatitis B, or hepatitis C.
- You have a history of a severe allergic reaction to contrast dyes (used in scans) or to biological medicines.
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
Time to First Relapse
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.