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Taking people in CroatiaPhase 2

Testing Different Doses of BI 3000202 in Systemic Lupus Erythematosus

Tests different doses of an oral drug against placebo in adults with lupus.

Key facts

Who runs it
Boehringer Ingelheim
Where
Grad Zagreb, Osijek, Rijeka, and Zagreb, CroatiaSee the 4 sitesAlso in 20 other countries, 136 sites
Trial code
Registry title
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Status
Recruiting
Phase
Phase 2
People taking part
405 people, planned
Started
20 Apr 2026
Expected to end
8 Jul 2029
Type of study
Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • BI 3000202
  • Placebo
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with systemic lupus erythematosus (SLE) that is moderately to severely active. It tests different doses of BI 3000202 tablets against placebo for 1 year.

Age
From 18 to under 75 years.
Sex
Men and women can join.
Disease stage
SLE confirmed at least 24 weeks before screening, with active disease: SLEDAI-2K score of 6 or more, clinical SLEDAI-2K score of 4 or more, and at least 1 BILAG A and/or 1 BILAG B grade.
Earlier treatment
Must be on SLE background treatment: at most 1 immunosuppressant and/or 1 antimalarial for at least 8 weeks, at a stable dose for at least 4 weeks. Oral corticosteroids up to 30 mg/day prednisone or equivalent, stable for at least 2 weeks, are allowed.
Biomarker or test result
At screening, at least one positive: antinuclear antibodies (ANA) 1:80 or higher, anti-dsDNA antibody, or anti-Smith antibody.

Main reasons for not taking part

  • Drug-induced SLE
  • Scleroderma or other connective tissue disease that would interfere with the results
  • Active or unstable lupus affecting the brain or nerves
  • Lupus nephritis that may need a treatment change or has unstable or high kidney test results
  • Oral corticosteroids above 30 mg/day at screening

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years
  • Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 24 weeks prior to screening
  • At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody; Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points
  • At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator
  • On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply

Who cannot take part

  • Drug-induced SLE
  • Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Further exclusion criteria apply
  • Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments
  • Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy
  • Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or >2 × Upper Limit of Normal (ULN) and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or > 3mg/mg (339 mg/mmol)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 74 years old?

Where in Croatia

Also in 20 other countries, 136 sites

  • Poliklinika Solmed d.o.o.Grad Zagreb, CroatiaTaking people
  • Klinički bolnički centar OsijekOsijek, CroatiaTaking people
  • Specijalna Bolnica MedicoRijeka, CroatiaTaking people
  • Poliklinika BonifarmZagreb, CroatiaTaking people

About the trial

What the trial wants to find out

This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.

Read full original descriptionShow less

Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.

Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.

The 5 groups in the trial

  • Arm 1: BI 3000202 dose 1Treatment being tested

    Treatment: BI 3000202

  • Arm 2: BI 3000202 dose 2Treatment being tested

    Treatment: BI 3000202

  • Arm 3: BI 3000202 dose 3Treatment being tested

    Treatment: BI 3000202

  • Arm 4: BI 3000202 dose 4Treatment being tested

    Treatment: BI 3000202

  • Arm 5: PlaceboPlacebo, for comparison

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)
Plain-language title
Testing Different Doses of BI 3000202 in Systemic Lupus ErythematosusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07409181, who can take part
Record updated
12 November 2026