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Evaluating Anifrolumab for Active Proliferative Lupus Nephritis

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Phase 3 Interventional AstraZeneca · NCT05138133

This study is testing if an intravenous medication called anifrolumab can help adults with active proliferative lupus nephritis feel better compared to a placebo while they receive standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsBelimumab, anifrolumab, cyclophosphamide, antifrolumab
Locations228 sites (Birmingham, Alabama and 227 other locations)
Trial IDNCT05138133 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to assess the efficacy and safety of anifrolumab, an intravenous medication, in adult patients diagnosed with active proliferative lupus nephritis. The study is designed as a multicenter, randomized, double-blind, placebo-controlled trial, comparing anifrolumab to a placebo in conjunction with standard of care treatments. Approximately 360 participants will be enrolled and monitored over a treatment period of up to 116 weeks, with a focus on patients with Class III or IV lupus nephritis. The trial will evaluate the drug's impact on disease progression and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with active proliferative lupus nephritis classified as Class III or IV, with or without Class V.

Not a fit: Patients with a diagnosis of pure Class V lupus nephritis or those with significant underlying conditions that predispose them to infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from active proliferative lupus nephritis.

How similar studies have performed: Previous studies have shown promise with similar approaches in treating lupus nephritis, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Exclusion Criteria:

1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
2. 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).
3. Evidence of hepatitis C or active hepatitis B.
4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
5. 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.
6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
7. Known intolerance to ≤ 1.0 g/day of MMF.
8. Any history of severe COVID-19 infection.

Where this trial is running

Birmingham, Alabama and 227 other locations

+178 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus NephritisLupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.