. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Exclusion criteria
. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
. Evidence of hepatitis C or active hepatitis B.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial testing anifrolumab specifically for active proliferative lupus nephritis, does my diagnosis fit closely enough with what they're studying that it would even be worth considering?
2The main goal of this trial is measuring Complete Renal Response — can you explain what that means for kidney function, and how realistic that outcome is for someone in my situation compared to what standard treatment might achieve?
3The trial is no longer enrolling new participants — does that mean I've missed the window, or are there related studies or expanded access programs using anifrolumab that might still be open to me?
4Since anifrolumab is being added on top of existing lupus nephritis treatment in this study, what does that mean for the number of medications I'd be managing, and are there known risks from combining treatments that we should talk through?
5Given that standard-of-care treatments for proliferative lupus nephritis already exist, would you recommend I try those first before looking at a trial like this, or is there a reason this approach might make more sense for my case right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group
. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.