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Study on Anifrolumab for Adults with Active Lupus Nephritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Active Proliferative Lupus Nephritis, a condition where the immune system attacks the kidneys, causing inflammation and damage. The study will evaluate the effectiveness and safety of a treatment called Anifrolumab, which is given as a concentrate for solution for infusion, meaning it is administered directly into the bloodstream through a vein. Participants in the study will receive either Anifrolumab or a placebo, which is a substance with no active medication, to compare the outcomes.

The purpose of the study is to determine how well Anifrolumab works in helping patients achieve a complete renal response, which means improving kidney function and reducing inflammation. The study will involve regular visits to the clinic for infusions and monitoring over a period of time. Participants will be closely observed to ensure their safety and to track any changes in their condition.

Throughout the study, participants will receive standard care for their condition in addition to the study treatment. The goal is to see if adding Anifrolumab to the usual care can provide better outcomes for patients with Active Proliferative Lupus Nephritis. The study will help researchers understand if this treatment can be a beneficial option for managing this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the study medication, anifrolumab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The study medication, Saphnelo 300 mg, is administered as a concentrate for solution for infusion. This means it is given through a vein, a method known as intravenous use.

    The infusion is scheduled to occur at regular intervals as determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes measuring the urine protein to creatinine ratio and estimated glomerular filtration rate (eGFR) to evaluate kidney function.

    Participants will also be monitored for any side effects or adverse reactions to the medication.

  4. Step 4

    Primary evaluation

    The primary goal is to achieve a complete renal response (CRR) by Week 52. This involves meeting specific criteria related to kidney function, such as maintaining a urine protein to creatinine ratio of 0.5 mg/mg or less and an eGFR of 60 mL/min/1.73 m² or higher.

  5. Step 5

    Secondary evaluation

    Secondary evaluations include sustained reduction in oral corticosteroid (OCS) dosage and time to sustained CRR. The aim is to reduce the OCS dose to 7.5 mg/day or less by Week 24 and maintain this dosage through Week 52.

    Other assessments include cumulative urine protein to creatinine ratio and time to renal events, such as end-stage kidney disease or significant changes in kidney function.

  6. Step 6

    Study duration

    The study is expected to continue until March 2028, with regular follow-ups and assessments throughout this period to ensure comprehensive evaluation of the treatment's efficacy and safety.

Who can join the trial?

13 criteria

  • Must be between 18 and 70 years old at the time of screening.
  • Must have a negative COVID-19 test result and no known or suspected exposure to COVID-19 within 2 weeks before screening.
  • Must weigh at least 40 kilograms (about 88 pounds).
  • Females who are or have been sexually active and have an intact cervix must have a normal cervical cancer screening test result within the last 2 years.
  • Must use contraception as per local regulations for clinical studies.
  • Must meet the updated 2019 criteria for **SLE** (Systemic Lupus Erythematosus).
  • Must have a positive test result for **ANA** (Antinuclear Antibody), **anti-dsDNA** (anti-double-stranded DNA), or **anti-Sm** (anti-Smith) during screening or historically.
  • Must have a urine protein to creatinine ratio greater than 1 mg/mg, based on two samples taken during screening.
  • Must have active **proliferative LN** (Lupus Nephritis) Class III or IV, with or without Class V, based on a kidney biopsy within 6 months before signing the consent form or during screening. The participant must need high-dose corticosteroids and immunosuppressive therapy.
  • Must have an **eGFR** (estimated Glomerular Filtration Rate) of at least 35 mL/min/1.73 m², which is a measure of kidney function.
  • Must have adequate peripheral venous access, meaning veins that can be used for blood draws or infusions.
  • Must have a chest X-ray or CT scan showing no active infection, no signs of tuberculosis (TB), no cancer, and no suspicious lung nodules. Any abnormalities should be related to SLE.
  • Must meet all TB criteria: no signs or symptoms of active TB, no history suggesting active TB, a chest X-ray showing no active or past TB, no recent contact with someone with active TB, or if there was contact, must have been evaluated and treated for latent TB if needed. Must have a TB test with results as per study rules.

Who cannot join the trial?

10 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to similar medications.
  • Using certain medications that might affect the study results.
  • Having a recent history of drug or alcohol abuse.
  • Having an active infection that requires treatment.
  • Having received a live vaccine within a certain time before the study.
  • Having a history of certain types of cancer.
  • Having a condition that affects the immune system, other than lupus nephritis.
  • Having participated in another clinical trial recently.
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Investigated drugs

Anifrolumab is a medication being studied for its effectiveness in treating adults with active proliferative lupus nephritis, a type of kidney inflammation caused by lupus. The trial aims to see how well anifrolumab works when added to the standard of care treatments for this condition.

What is already known about the treatment

Anifrolumab – Anifrolumab is administered intravenously, typically through an infusion. It is currently being studied in clinical trials, particularly in a Phase 3 study, to assess its effectiveness and safety for treating active proliferative lupus nephritis. The main therapeutic indication for anifrolumab is lupus nephritis, a kidney disorder associated with lupus. At the molecular level, anifrolumab works by blocking the type I interferon receptor, which plays a role in the inflammation process associated with lupus. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Active Proliferative Lupus Nephritis – This is a kidney condition that occurs as a complication of systemic lupus erythematosus, an autoimmune disease. In this condition, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The term "proliferative" refers to the increase in the number of cells in the kidney's filtering units, which can impair their function. Over time, this can result in protein leakage into the urine and reduced kidney function. Symptoms may include swelling, high blood pressure, and changes in urine output. The progression of the disease can vary, with periods of flare-ups and remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506359-68-00Protocol codeIRIS, D3466C00001Estimated enrolment336 patientsSponsorAstraZeneca AB

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