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Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

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What is this trial about?

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

This study is being done in adults with Systemic Lupus Erythematosus, a long-term disease in which the immune system attacks the body’s own tissues. The treatment being tested is nipocalimab, given as an injection under the skin, compared with placebo. The purpose of the study is to see whether nipocalimab can reduce disease activity in people with this condition.

The study is a Phase 3 trial, which means it is being done in a larger group of people to better understand how well the treatment works and how safe it is. People taking part are assigned by chance to receive either nipocalimab or placebo. The treatment is given over time, and the study team follows participants through the treatment period to observe how the disease changes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the study

    After joining the study, you are placed into one of two treatment groups by chance. The study is randomized, which means the treatment assignment is made by a random process.

    The study is double-blind, which means that neither you nor the study team will know whether you are receiving nipocalimab or placebo during the study.

    The study is placebo-controlled, which means one group receives placebo, a study treatment that does not contain nipocalimab.

  2. Step 2

    Study treatment period

    You receive either nipocalimab or placebo as a subcutaneous injection, which means an injection given under the skin.

    Nipocalimab is given as a solution for injection. The listed dose is 0 in the source data, and no dosing frequency or treatment duration is specified in the source data.

    The placebo is given by the same subcutaneous route. No dose, frequency, or treatment duration is specified in the source data.

    You continue in the study while the treatment period is carried out according to the study plan.

  3. Step 3

    Assessment of treatment effect

    Your disease activity is checked during the study to see how well the treatment is working.

    The main study result is measured at week 52 using the sri-4 result, which stands for systemic lupus erythematosus responder index-4. This is a combined measure used to show whether your lupus disease activity has improved.

  4. Step 4

    End of the study

    The study continues until the planned end of the trial period.

    The estimated study end date is 2031-02-21.

Who can join the trial?

5 criteria

  • Adult at the time of signing the informed consent form, meaning the person must be legally an adult when agreeing to join the study.
  • Have a diagnosis of systemic lupus erythematosus (SLE).
  • Have at least 1 positive autoantibody, meaning a blood test must show at least one antibody that reacts against the body’s own tissues.
  • Have a SLEDAI-2K score available, which is a doctor-used score that measures how active the lupus is.
  • Have a BILAG score available, which is another doctor-used score that checks how active the disease is in different body systems.

Who cannot join the trial?

5 criteria

  • Any condition that the study doctor thinks would make participation not in the patient’s best interest.
  • Any clinically significant laboratory abnormality, meaning an important abnormal result in blood, urine, or other lab tests that is not considered suitable for the study.
  • Comorbidities that require systemic glucocorticoids (GCs), meaning another medical condition that needs steroid medicine taken by mouth, by injection, or in a way that affects the whole body.
  • Inflammatory diseases, meaning other conditions that cause ongoing swelling, redness, or irritation in the body.
  • A major surgical procedure before screening, meaning a large operation done before the study checks whether the person can join.
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Investigated drugs

nipocalimab is the study medicine being tested in this trial. It is given as an injection under the skin. The goal of the study is to see whether it can help lower disease activity in adults with moderate to severe systemic lupus erythematosus, which is an autoimmune disease where the immune system attacks the body’s own tissues.

What is already known about the treatment

Nipocalimab - Nipocalimab is given as a solution for injection under the skin, which means it is administered by subcutaneous injection. It is an investigational medicine in clinical trials, but it has been studied in medical literature as a targeted treatment for immune system disorders. Its main use is being tested in diseases such as systemic lupus erythematosus, where the immune system attacks the body by mistake. Nipocalimab is a monoclonal antibody that blocks a protein called FcRn, which helps lower certain harmful antibodies in the blood, and it is classified as an immunomodulating monoclonal antibody.

Investigated diseases

Systemic Lupus Erythematosus - Systemic lupus erythematosus is a long-term autoimmune disease in which the immune system mistakenly attacks healthy tissues. It can affect the skin, joints, kidneys, blood, and other organs. The illness often develops in periods of flare and remission, with symptoms that may come and go over time. Its course can vary widely from mild to more widespread disease, and new organs may become involved as it progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523552-31-00Protocol code80202135SLE3001Estimated enrolment600 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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