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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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

Key facts

Study ID

NCT05138133

Run by

AstraZeneca

People needed

363

Starts

2022-02-15

Expected to finish

2028-10-04

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — La Palma, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Upland, California, United States
• Research Site — Plantation, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Summit, New Jersey, United States
• Research Site — Manhasset, New York, United States
• Research Site — New York, New York, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Middleburg Heights, Ohio, United States
• Research Site — Colleyville, Texas, United States
• Research Site — Edinburg, Texas, United States
• Research Site — El Paso, Texas, United States
• Research Site — Houston, Texas, United States
• 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 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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