Last updated 3 days ago
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
360 patients around the world
Available in Mexico, United States, Peru, Argentina
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled
study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as
added to SOC (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 142 weeks, including screening and follow-up. Double-blind period
will be 76 weeks. Participants who complete double-blind treatment period may enter
open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the
enrolled participants will be randomly assigned to study intervention (anifrolumab or
placebo) at a ratio of 1:1 during double-blind treatment period.
AstraZeneca
4Research sites
360Patients around the world
This study is for people with
Lupus
Lupus nephritis
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classificationRenal biopsy obtained within 6 months prior to signing the ICF or during Screening PeriodUrine 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 criteriaNo signs of symptoms of active TB prior to or during screening or no treatment for latent TB
- A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during ScreeningKnown 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 BAny history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situReceipt 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 ICFPrevious receipt of >◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICFKnown intolerance to ≤ 1.0 g/day of MMFAny history of severe COVID-19 infection
Sites
Organización Médica de Investigación (OMI)
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S. - Colombia
Recruiting
Centro Integral en Reumatología S.A. de C.V. - CIRSA Reumatología
Recruiting
StudyIRIS
SponsorAstraZeneca
Study typeInterventional
Conditions
Lupus nephritis
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05138133
