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 (NCT04058028) enrolled 244 adults with systemic lupus erythematosus (lupus) across four groups: 62 received a placebo (a dummy treatment with no active ingredient), 58 received a 70 mg dose of rozibafusp alfa, 36 received a 280 mg dose, and 88 received a 420 mg dose. The trial's main goal was to measure how many participants met a set of pre-defined criteria — known as an "SRI-4 response" — showing improvement in their lupus disease activity at 52 weeks, without their overall condition getting worse in other ways. The reported data shows that, for the primary measure at 52 weeks, 26 out of 62 placebo participants, 29 out of 58 in the 70 mg group, 21 out of 36 in the 280 mg group, and 35 out of 88 in the 420 mg group met the SRI-4 response criteria. For the secondary measures, the reported data shows that at 24 weeks, 33 placebo, 30 (70 mg), 20 (280 mg), and 46 (420 mg) participants met the SRI-4 criteria. A different disease-activity measure called BICLA response at 52 weeks was met by 21 placebo, 20 (70 mg), 15 (280 mg), and 29 (420 mg) participants. For a "low disease activity" measure at 52 weeks, the numbers were 12, 18, 6, and 21 respectively. A smaller sub-group measure — looking at people who also managed to reduce their steroid dose to a low level and sustain that through to week 52 — was met by 5 placebo, 1 (70 mg), 2 (280 mg), and 8 (420 mg) participants. It is also worth noting that not all participants completed the study — for example, 26 of the 62 placebo participants and 42 of the 88 highest-dose participants did not complete it, though the reasons were not detailed in the submitted data. 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 37491104) ↗
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 2 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 are between 18 and 75 years old at the time of your screening visit.
- You have agreed to take part and given your consent before any study activities begin.
- You have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) according to specific 2019 medical guidelines, and a particular antibody test (ANA) showed a result of 1:80 or higher at your screening visit.
- Your lupus is active enough to score at least 6 points on a standard lupus activity measurement tool (called hSLEDAI), with at least 4 of those points coming from physical symptoms rather than lab results alone.
- If your joint pain is being counted toward your score, it must affect joints in your hands or wrists, with at least 3 joints that are both tender and swollen.
- If you have lupus-related hair loss, it must be non-scarring hair loss, not a different type of hair loss condition, and must meet a minimum severity score (confirm with trial site).
- If you have mouth ulcers related to lupus, their location and appearance must be recorded by the study doctor.
- If you have eye inflammation (scleritis or episcleritis) related to lupus, this must be confirmed as stable and documented by an eye doctor (confirm with trial site).
- If you have kidney involvement, your urine protein-to-creatinine ratio must be below 3000 mg/g, your physical symptom score must still be at least 4, and you must not have received strong kidney treatment (induction therapy) in the past year.
- If you have chest-related lupus symptoms (pleurisy or pericarditis), these must be supported by objective medical findings to count toward your score.
- You are currently taking one approved lupus medication (such as hydroxychloroquine, chloroquine, quinacrine, azathioprine, methotrexate, leflunomide, mycophenolate mofetil/mycophenolic acid, or dapsone), OR two of these medications where one must be an anti-malarial drug — unless you have a documented reason why you cannot tolerate these.
- Your lupus medication(s) have been taken for at least 12 weeks before screening, and the dose has been stable for at least 8 weeks before screening.
- If you are taking oral corticosteroids (such as prednisone), your dose is no more than 20 mg per day (or the equivalent), and the dose has been stable for at least 2 weeks before your screening visit.
Who may not be able to join:
- Your urine protein-to-creatinine ratio is 3000 mg/g or higher at screening, or you have received strong treatment (induction therapy) for lupus kidney disease within the past year.
- You have had active lupus affecting your brain or nervous system within the past year — this includes conditions such as seizures, psychosis, vision nerve problems, stroke-like symptoms, or other serious neurological issues related to lupus.
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: MD, Amgen
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
Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.