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Clinical Trials in China / NCT05138133
Active, not recruiting Phase 3

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

NCT05138133 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-02-15
Last updated
2026-07-31

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

AnifrolumabPlacebo

Anifrolumab: Anifrolumab intravenous infusion (IV)

Placebo: Placebo intravenous infusion (IV)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (164)

FacilityCityRegionStatus
Research Site Glendale Arizona
Research Site La Palma California
Research Site Los Angeles California
Research Site Upland California
Research Site Plantation Florida
Research Site Atlanta Georgia
Research Site Louisville Kentucky
Research Site Summit New Jersey
Research Site Manhasset New York
Research Site New York New York
Research Site Winston-Salem North Carolina
Research Site Middleburg Heights Ohio
Research Site Colleyville Texas
Research Site Edinburg Texas
Research Site El Paso Texas
Research Site Houston Texas
Research Site CABA Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site La Plata Argentina
Research Site Rosario Argentina
Research Site San Juan Argentina
Research Site Brussels Belgium
Research Site Leuven Belgium
Research Site Liège Belgium
Research Site Belo Horizonte Brazil
Research Site Campinas Brazil
Research Site Cuiabá Brazil
Research Site Maringá Brazil
Research Site Porto Alegre Brazil
Research Site Recife Brazil
Research Site Salvador Brazil
Research Site São José do Rio Preto Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Plovdiv Bulgaria
Research Site Sofia Bulgaria
Research Site Beijing China
Research Site Beijing China
Research Site Bengbu China

+ 124 more sites — see the full list on the official registry below.

On this site

📄 Saphnelo (anifrolumab) drug profile →

More AstraZeneca trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05138133 on ClinicalTrials.gov ↗ ← All trials in China