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Phase 3 study of ianalumab plus standard drug combination in adults and adolescents with systemic lupus erythematosus

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What is this trial about?

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

Systemic Lupus Erythematosus is an autoimmune condition in which the body’s immune system mistakenly attacks its own tissues, causing pain, fatigue, skin rashes, and possible damage to organs. Standard‑of‑care therapy usually includes medicines such as corticosteroids (drugs like prednisone that reduce inflammation). In this study the experimental medicine ianalumab is given as a subcutaneous injection (a shot placed under the skin) and is compared with a placebo (an inactive substance).

The purpose of the study is to find out whether adding ianalumab to the usual treatment leads to a better disease response than placebo, using the SRI-4 score at week 60 as the main measure. Participants are randomly assigned to receive either the drug or placebo for about a year, with regular clinic visits for safety checks and disease assessments while they continue their regular medicines; the dose of steroids may be lowered if the disease improves.

Researchers will record how many participants show improvement in disease activity, avoid serious flare‑ups, and are able to reduce steroid use to 5 mg per day or less. They will also monitor for side effects and collect blood samples to check drug levels and any immune reaction against the drug. The study ends after the 60‑week treatment period, followed by a short follow‑up phase.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and screening

    After joining the study, undergo screening procedures that include review of medical history, physical examination, and laboratory tests to confirm eligibility for the trial.

  2. Step 2

    Baseline visit

    Complete baseline assessments that record disease activity of systemic lupus erythematosus and collect blood samples for laboratory measurements.

    Begin standard‑of‑care oral medications as prescribed: entecavir 0.5 mg daily, tenofovir disoproxil 300 mg daily, tenofovir alafenamide 25 mg daily, and glucocorticoid 50 mg daily. each medication is taken by mouth according to the dosing schedule provided by the investigator.

  3. Step 3

    First injection

    Receive a single injection administered subcutaneous (under the skin) in a pre‑filled syringe. the injection contains either ianalumab 300 mg or a matching placebo solution. the assignment is double‑blind, so the participant does not know which product is administered.

  4. Step 4

    Regular dosing visits

    Return for additional injections according to the study schedule, typically every four weeks, until week 60. each visit includes administration of the same assigned product (ianalumab or placebo) and assessment of any adverse events.

  5. Step 5

    Interim follow‑up assessments

    Attend scheduled clinic visits (for example at weeks 4, 12, 24, 36, and 48) where blood samples are drawn, disease activity scores are recorded, and vital signs are measured.

    Report any side effects or new health problems to the study staff during each visit.

  6. Step 6

    Corticosteroid dose adjustment

    Between week 36 and week 60, the investigator may attempt to reduce the daily dose of prednisone (or equivalent corticosteroid) to 5 mg or less, or to the baseline dose if it is already lower, while monitoring disease control.

  7. Step 7

    Final efficacy assessment

    At week 60, a comprehensive evaluation is performed to determine whether the participant has achieved sri‑4 (a predefined improvement in disease activity).

    Additional secondary outcomes are measured, including flare‑up rates, corticosteroid dose, lupus low disease activity state, and patient‑reported pain scores.

  8. Step 8

    Study completion and follow‑up

    After the week 60 visit, the participant completes the active treatment phase of the trial.

    The study may include a post‑treatment follow‑up period for safety monitoring, during which final laboratory tests and antibody assessments are performed.

Who can join the trial?

6 criteria

  • Must be at least 12 years old at the time of screening (in some countries, such as those in the European Economic Area, you must be 18 years old or older).
  • Must have a diagnosis of systemic lupus erythematosus that meets the 2019 EULAR/ACR classification criteria (a set of guidelines doctors use to confirm the disease) and the diagnosis must have been made at least 6 months before screening.
  • Must have a blood test showing antineuclear antibodies (ANA) with a level of 1:80 or higher and a typical fluorescence pattern (these antibodies are proteins that mistakenly target the nucleus of cells, and the level indicates how many are present).
  • Must be currently taking at least one of the following medicines: corticosteroids (drugs that reduce inflammation), an anti‑malarial medication (a drug originally used for malaria that also helps control lupus), or another disease‑modifying antirheumatic drug (DMARD) (a medication that changes the course of the disease).
  • Must have a disease‑activity score called SLEDAI‑2K of 6 points or more (this score measures how active the disease is, not counting fever, lupus headache, hair loss, or brain problems) and must also meet one of the following on the British Isles Lupus Assessment Group‑2004 (BILAG‑2004) assessment: either a level A (indicating serious activity) in at least one organ system, or level B (moderate activity) in at least two organ systems.
  • Must weigh at least 35 kilograms at the time of screening.

Who cannot join the trial?

18 criteria

  • You have already received ianalumab before.
  • You have an active tuberculosis infection (a serious bacterial lung disease).
  • You have a known immune system problem, such as a positive HIV test result.
  • Your blood tests show any of the following very low values: platelets less than 25,000 per microliter (platelets help blood clot), hemoglobin less than 8 g/dL (or less than 7 g/dL if caused by lupus; hemoglobin carries oxygen), or absolute neutrophil count less than 0.8 × 10⁹/L (absolute neutrophil count measures a type of white blood cell that fights infection).
  • You have severe organ failure or a life‑threatening disease at the time of screening.
  • You have severe lupus kidney disease, shown by urine protein above 2 g per day (or an equivalent spot urine test; this is called proteinuria).
  • Any other medical, surgical, psychiatric, or physical condition that could make participation unsafe.
  • You received a live or weakened (attenuated) vaccine within 4 weeks before the first dose (live/attenuated vaccine).
  • You have another serious disease that is not under control and could put you at risk or interfere with the study.
  • You have non‑lupus conditions such as asthma, gout, or hives that require regular oral steroids.
  • You have a history of cancer, except for a small skin basal cell carcinoma or early‑stage cervical cancer that has not spread.
  • You are pregnant or breastfeeding (pregnant or breastfeeding women).
  • You have taken high‑dose steroids, calcineurin inhibitors, JAK inhibitors, or other disease‑modifying drugs (DMARDs) within 12 weeks before screening.
  • You have taken cyclophosphamide, immunoglobulins, plasmapheresis, anti‑type I interferon receptor agents, anti‑CD40 agents, CTLA4‑Fc Ig, or B‑cell activating factor agents within 24 weeks before screening, or belimumab within 12 weeks before screening.
  • You have received any B‑cell depleting therapy (except ianalumab) within 36 weeks before randomization, or your B‑cell count is still below the normal range (B‑cell depleting therapy).
  • You have used traditional Chinese medicines within 30 days before randomization (traditional Chinese medicines).
  • You have an active viral, bacterial, or other infection that requires intravenous or intramuscular treatment.
  • You have a chronic infection with hepatitis B or hepatitis C (hepatitis B or hepatitis C).
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Investigated drugs

  • Entecavir

    is an oral medicine that treats chronic hepatitis B infection. In this study it is given as part of the usual care to keep the liver healthy and protect patients who might have hepatitis B while they receive the study drug.

  • Emtricitabine and Tenofovir disoproxil

    are combined in one pill (often known as Truvada) to treat and prevent hepatitis B and HIV. The combination is provided as background therapy to control any underlying viral infection and support liver safety during the trial.

  • Tenofovir alafenamide

    is another oral hepatitis B medication that works like tenofovir disoproxil but is gentler on the kidneys. It is included in the standard‑of‑care regimen to further protect liver function while participants take the investigational treatment.

  • Glucocorticoids

    are steroid medicines that lower inflammation and suppress the immune system. They are commonly used in lupus care, and in this trial they are part of the regular treatment to help control disease activity while the new drug is being tested.

  • Ianalumab

    is the experimental drug being studied. It is given by subcutaneous injection and is designed to target a specific immune pathway to reduce lupus activity. The trial is checking whether adding ianalumab to the usual lupus medicines leads to a better disease response compared with placebo.

What is already known about the treatment

  • Entecavir

    Entecavir is taken as an oral tablet of 0.5 mg and is approved for treating chronic hepatitis B infection. It works by blocking an enzyme the virus needs to copy its DNA, which stops the virus from growing. This medication is classified as an antiviral nucleoside analog and is widely used in medical practice and research. It is given once daily to help control liver disease caused by hepatitis B.

  • Emtricitabine/tenofovir disoproxil

    This combination drug is taken as an oral tablet containing 300 mg of each component and is approved for HIV infection and chronic hepatitis B. Both ingredients block a viral enzyme called reverse transcriptase, preventing the virus from making new copies of its genetic material. The product belongs to the class of nucleoside/nucleotide reverse transcriptase inhibitors and is a standard part of many antiretroviral regimens. It is usually taken once daily with food.

  • Tenofovir alafenamide

    Tenofovir alafenamide is an oral tablet of 25 mg used to treat HIV infection and chronic hepatitis B. It enters cells more efficiently than older forms of tenofovir, allowing lower doses while still stopping the virus from replicating by inhibiting its reverse transcriptase enzyme. This medication is classified as a nucleotide reverse transcriptase inhibitor and is approved and widely prescribed. It is taken once daily, often as part of a combination therapy.

  • Ianalumab

    Ianalumab is given as a subcutaneous injection of 300 mg using a pre‑filled syringe and is being studied for patients with systemic lupus erythematosus. It is a monoclonal antibody that blocks a protein called BAFF, which helps reduce the activity of B‑cells that drive the disease. The drug belongs to the immunomodulator class of biologic therapies and is not yet approved, being evaluated in phase 3 trials. Treatment is administered under medical supervision at regular intervals.

  • Glucocorticoids

    Glucocorticoids are taken orally or by injection, often at doses around 50 mg, and are commonly used to lower inflammation in many conditions, including lupus. They work by dampening the body’s immune response, which reduces swelling and pain. These drugs are classified as corticosteroids and have been a mainstay of therapy for decades. They are prescribed by doctors as part of standard care to control flare‑ups.

Investigated diseases

Systemic Lupus Erythematosus - Systemic Lupus Erythematosus is an autoimmune condition in which the immune system mistakenly attacks healthy tissues throughout the body. It can affect the skin, joints, kidneys, heart, lungs, and brain, leading to periods of increased activity called flares. During a flare, symptoms such as joint pain, skin rash, and fatigue become more noticeable, while between flares the disease may be quieter. Over time, repeated inflammation can cause gradual damage to the affected organs. The pattern of disease activity varies among individuals, with some experiencing frequent flares and others having milder, infrequent episodes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508498-97-00Protocol codeCVAY736F12301Estimated enrolment398 patientsSponsorNovartis Pharma AG

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