Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Official Title

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

Details

This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.

Keywords

Lupus Nephritis, Lupus Nephritis, anifrolumab, Systemic Lupus Erythematosus, intravenous, Nephritis, Anifrolumab

Eligibility

You can join if…

Open to people ages 18-70

  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

You CAN'T join if...

  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.

Locations

  • Research Site not yet accepting patients
    Los Angeles California 90095 United States
  • Research Site not yet accepting patients
    Orange California 92868 United States
  • Research Site accepting new patients
    Upland California 91786 United States
  • Research Site accepting new patients
    Glendale Arizona 85306 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05138133
Phase
Phase 3 Lupus Research Study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated