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Different doses of BI 3000202 for adults with lupus

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)

Phase 2 Interventional Boehringer Ingelheim · NCT07409181

We are testing whether different doses of BI 3000202 can help adults with systemic lupus erythematosus (lupus).

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment405 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsprednisone
Locations132 sites (Beverly Hills, California and 131 other locations)
Trial IDNCT07409181 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2 trial assigns adults with active SLE to one of five groups: four different doses of BI 3000202 or a matching placebo. Participants take study tablets for one year while continuing their usual SLE treatments, and they visit the study site regularly for safety and effectiveness checks. Doctors record disease activity and any side effects and then compare outcomes across the dose groups to identify the best dose. The trial focuses on adults with confirmed SLE and measurable disease activity at screening.

Who should consider this trial

Good fit: Adults aged 18 to under 75 with a confirmed EULAR/ACR diagnosis of SLE, active disease (SLEDAI-2K ≥6 and clinical SLEDAI-2K ≥4) with at least one BILAG A or B, and on stable background therapy with at most one immunosuppressant and/or one antimalarial are ideal candidates.

Not a fit: People with mild or inactive lupus, those taking more than one immunosuppressant, or individuals outside the allowed age range are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, BI 3000202 could lower lupus disease activity and improve symptoms for adults with SLE.

How similar studies have performed: Other targeted SLE therapies such as belimumab and anifrolumab have shown benefit in randomized trials, but BI 3000202 is a new experimental treatment without phase 3 evidence yet.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
2. 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
3. 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
4. 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
5. 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.

Exclusion Criteria:

1. Drug-induced SLE
2. 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
3. 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
4. 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)
5. Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.

Where this trial is running

Beverly Hills, California and 131 other locations

+82 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusLupus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.