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 (NCT02794285) was a long-term extension study involving people with systemic lupus erythematosus (lupus) who had previously taken part in related trials of a medicine called anifrolumab. A total of 547 participants were enrolled across four groups, depending on what they had received previously and what they were given during this extension phase. The trial was primarily measuring how often certain pre-specified medical events occurred across the groups over time, including serious infections, certain types of cancer, shingles, and major heart events, as well as serious adverse events (that is, significant medical events that required hospitalisation or were life-threatening, among other criteria). The reported data shows these event rates expressed as the number of events per 100 participant-years (a way of accounting for the fact that different people were in the study for different lengths of time). For the pre-specified events of special interest, the reported rates were: 11.0 for the group that received anifrolumab 300 mg throughout; 9.6 for the group that received placebo throughout; 12.9 for the group that switched from placebo to anifrolumab 300 mg; and 12.5 for the group that had previously received a lower dose (150 mg) and then continued on 300 mg. For serious adverse events, the reported rates were: 8.5, 11.2, 10.1, and 10.7 respectively across those same four groups. 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 40324450) ↗
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 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 must have already taken part in and completed one of two specific earlier studies (D3461C00004 or D3461C00005), receiving either the study drug (anifrolumab) or a placebo for the full 52-week treatment period
- You must have suitable veins that allow for an intravenous drip or blood draws
- If you are female and have a cervix, you must have had a recent cervical smear (Pap smear) showing no cancer, either within 90 days before or 30 days after the start of this study (confirm with trial site regarding local guidelines)
- You must meet specific tuberculosis (TB) screening requirements based on your TB test results at the end of the earlier study — this includes having a negative, newly positive, previously positive, or uncertain TB test result, each with specific follow-up steps such as chest X-rays or preventive TB treatment if needed (confirm with trial site for details)
- In the opinion of the study doctor, you must be able to understand and complete the consent forms and all study-related assessments
Who may not be able to join:
- You have taken certain immune-suppressing medications at high doses within the last 60 days, including azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, or mizoribine above specific limits (confirm with trial site for exact doses)
- You have received another experimental drug or treatment (other than anifrolumab) within the past 4 weeks or within a certain timeframe based on that drug's clearance from the body, whichever is longer
- You have received a live or weakened vaccine within the past 8 weeks before the study start, or a BCG vaccine (a specific TB vaccine) at any point between finishing the earlier study and starting this one
- You currently have severe, active lupus (SLE) that is seriously affecting your kidneys or your brain and nervous system
- You have any condition that makes you more likely to get infections, including having HIV
- If you tested positive for a Hepatitis B marker at the start of the earlier study, your Hepatitis B virus levels in the blood must remain below a certain level to stay eligible for this study
- You have had a serious opportunistic infection (a severe infection that occurs when the immune system is weakened) requiring hospital treatment or intravenous antibiotics within the past 3 years
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: Kenneth Kalunian, MD, University of California, San Diego
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs); EAIRs of Serious Adverse Events (SAEs)
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.