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BI 3000202 in Patients 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 clinical trial is studying systemic lupus erythematosus (SLE), a disease in which the immune system attacks the body’s own tissues and can cause swelling, pain, rash, tiredness, and damage to organs. The study will test BI 3000202, an oral film-coated tablet taken by mouth, and compare different dose levels with placebo to see whether the treatment may help people with moderate to severe SLE. The purpose of the study is to evaluate how well and how safely BI 3000202 works in this disease.

In the study, people are assigned by chance to receive one of the dose regimens of BI 3000202 or placebo. The study is double-blind, which means neither the participants nor the study team knows which treatment is given. Treatment is continued for a period of time, and the study follows how the disease changes over several months, including whether symptoms improve and whether steroid medicine can be lowered. The study also looks at whether the disease reaches a lower level of activity, meaning it is calmer and causing fewer problems.

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

    Study treatment begins

    You start the trial after joining the study and are assigned to one of the study groups in a random way. The study is placebo-controlled, which means that one group receives the study medicine and another group receives a placebo that matches the study medicine but does not contain the active ingredient.

    The study is double-blind, which means that you and the study team do not know which treatment you receive during the trial.

  2. Step 2

    Taking the study medicine

    You take BI 3000202 by mouth as a film-coated tablet. The study also includes a placebo matching BI 3000202.

    The source data list BI 3000202 as the study medicine, but the exact dose, frequency, and duration of administration are not provided in the source data. The dose is shown as 00 mg in the source data.

  3. Step 3

    Study follow-up through week 32

    Your response to treatment is assessed at Week 32. The main result is whether you reach an SRI-4 response at this time.

    SRI-4 means Systemic Lupus Erythematosus Responder Index-4. This is a measure used to show whether lupus symptoms have improved.

  4. Step 4

    Assessment of steroid use at week 32

    At Week 32, the study also checks whether you reach an SRI-4 response and have reduced oral corticosteroid use to 5 mg/day or less of prednisone or an equivalent dose.

    Oral corticosteroid means a steroid medicine taken by mouth. Prednisone or equivalent means a similar steroid dose that has the same effect.

  5. Step 5

    Assessment of low disease activity at week 32

    At Week 32, the study checks whether you reach LLDAS.

    LLDAS means Lupus Low Disease Activity State. This means the lupus is at a low level of activity.

  6. Step 6

    Continued follow-up through week 52

    Your response to treatment is checked again at Week 52. The study measures whether you reach an SRI-4 response at that time.

    The source data do not provide any other treatment changes, medication schedules, or additional trial steps beyond these study assessments.

Who can join the trial?

7 criteria

  • Adult men or women, at least 18 years old and younger than 75 years old, or within the local adult age limit if different.
  • A confirmed diagnosis of systemic lupus erythematosus (SLE) made at least 24 weeks before the screening visit. Screening means the first set of tests and checks used to see if a person can join the study.
  • At least one positive antibody test at screening: antinuclear antibodies (ANA) at a level of at least 1:80, or a positive anti-dsDNA antibody test, or a positive anti-Smith antibody test. Antibodies are proteins made by the immune system.
  • A total SLEDAI-2K score of at least 6 points, and a clinical SLEDAI-2K score of at least 4 points. This is a scoring system used by doctors to measure how active the illness is; a higher score means more active disease.
  • At screening, at least one BILAG A finding or at least one BILAG B finding, with disease activity judged to be high enough by both the study doctor and the reviewer. BILAG is another doctor scoring system used to measure which parts of the body are affected and how active the illness is.
  • Taking background treatment for SLE with no more than 1 immunosuppressant and/or 1 antimalarial for at least 8 weeks before screening, and the dose must have stayed the same for at least 4 weeks before screening. An immunosuppressant is a medicine that lowers immune system activity. An antimalarial is a medicine often used in lupus treatment.
  • Or taking oral corticosteroids at a dose of 30 mg/day or less of prednisone or an equivalent medicine, with the dose stable for at least 2 weeks before screening. Corticosteroids are anti-inflammatory medicines that reduce swelling and immune activity.

Who cannot join the trial?

7 criteria

  • Having drug-induced lupus, which means lupus caused by a medicine.
  • Having scleroderma, except for linear scleroderma that does not affect the study checks for lupus activity. Scleroderma is a condition that causes tightening and hardening of the skin and sometimes other tissues.
  • Having other connective tissue diseases that, in the doctor’s judgment, could interfere with reading the test results or with checking lupus symptoms. Connective tissue diseases are illnesses that affect tissues that support and hold parts of the body together.
  • Having active or unstable lupus-related nervous system symptoms. This includes certain conditions in the brain, nerves, or spinal cord that are considered severe on the BILAG A scale. Exceptions are mononeuritis/mononeuropathy multiplex (damage to several individual nerves), chorea (involuntary jerking movements), and polyneuropathy (damage to many nerves).
  • Having lupus nephritis that may need a change in immune-modifying treatment, or having kidney test results that are not stable. This includes serum creatinine above 2 times the upper limit of normal or unstable, and/or UPCR above 3 mg/mg or unstable. Serum creatinine is a blood test that checks kidney function. UPCR is a urine test that measures protein in the urine compared with creatinine.
  • Taking oral corticosteroids at a dose of more than 30 mg per day at screening. Oral corticosteroids are steroid medicines taken by mouth, such as prednisone or a similar medicine.
  • Meeting any other exclusion rule in the study that is not listed here.
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Investigated drugs

BI 3000202: This is the study medicine being tested in people with moderate to severe systemic lupus erythematosus, a long-term disease where the immune system attacks the body’s own tissues. It is taken by mouth as a tablet. The trial is checking whether this medicine can help improve lupus symptoms and disease activity, and whether it is safe to use. Participants receive different treatment regimens of this medicine so researchers can see how well it works compared with no active treatment.

What is already known about the treatment

BI 3000202 - BI 3000202 is an oral medicine given as a film-coated tablet, so it is taken by mouth. It is an investigational substance, meaning it is still being studied in medical research and is not yet a well-established standard treatment in medical practice or medical literature. It is being tested for moderate to severe systemic lupus erythematosus, an illness where the immune system attacks the body’s own tissues. Its exact molecular action and drug class are not fully known from the available trial information, but it is designed to modify the immune response and may help reduce harmful inflammation and disease activity.

Investigated diseases

Systemic lupus erythematosus - Systemic lupus erythematosus is a long-term autoimmune disease in which the immune system attacks the body's own tissues. It can affect the skin, joints, kidneys, blood cells, heart, lungs, and brain. The disease often develops in episodes, with periods of worsening symptoms followed by periods of improvement. Symptoms and affected organs can change over time, and the illness may gradually involve more than one part of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523488-39-00Protocol code1509-0004Estimated enrolment216 patientsSponsorBoehringer Ingelheim Espana S.A.

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