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 (IRIS)

  • STATUS
    Recruiting
  • End date
    Jan 29, 2027
  • participants needed
    360
  • sponsor
    AstraZeneca
Updated on 20 September 2022
chronic kidney disease
nephritis
anifrolumab

Summary

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

Description

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.

Details
Condition Lupus Nephritis
Treatment Placebo, Anifrolumab
Clinical Study IdentifierNCT05138133
SponsorAstraZeneca
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period
Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)
Fulfills updated 2019 EULAR/ACR SLE classification criteria
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
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
Known intolerance to ≤ 1.0 g/day of MMF
Any history of severe COVID-19 infection
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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