What is BI 3000202 studying for systemic lupus erythematosus (SLE)?

BI 3000202 is being studied to see if different doses can help adults with moderate to severe SLE. The trial aims to find the best dose and assess how the medicine works compared to a placebo. This research is sponsored by Boehringer Ingelheim to better understand treatment options for SLE.

Who may be eligible for this systemic lupus erythematosus clinical trial?

Adults aged 18 to 74 with a confirmed diagnosis of SLE who meet specific disease activity criteria may be eligible. Both males and females can participate, and participants should be on stable SLE treatment with limited immunosuppressants or corticosteroids. Please review eligibility criteria for more details.

Is there any cost to participate in this systemic lupus erythematosus clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 74Years

All Genders

ID07409181

Randomized, Placebo-Controlled, Double-Blind Study Evaluating Oral BI 3000202 for Moderate to Severe Systemic Lupus Erythematosus

Led by Boehringer Ingelheim · Updated on 2026-05-29

405

Participants Needed

134

Research Sites

22 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a medicine called BI 3000202 in adults with moderate to severe systemic lupus erythematosus SLE. This study aims to find out if different doses of BI 3000202 help people with SLE and to determine the best dose. The trial is a randomized, placebo-controlled, double-blind Phase II study sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of five groups four groups receive different doses of BI 3000202, and one group receives a placebo tablet that looks identical but contains no medicine. All participants continue their usual SLE treatment while taking the study tablets daily for one year. The study includes regular visits and health checks during this period. During the study, participants visit the study site regularly for health assessments and monitoring of any side effects. Doctors compare the results between groups, focusing on the Systemic Lupus Erythematosus Responder Index SRI-4 response at Week 32 as the primary outcome. The total participation lasts slightly longer than one year to ensure thorough evaluation of treatment effects and safety.

CONDITIONS

Brief Title

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

Who Can Participate

Age: 18Years - 74Years

All Genders

Eligibility Criteria

You may qualify if you...

Male and female adults aged 18 to under 75 years
Confirmed diagnosis of systemic lupus erythematosus (SLE) meeting EULAR/ACR criteria at least 24 weeks before screening
Positive test for antinuclear antibodies, anti-double-stranded DNA antibody, or anti-Smith antibody at screening
Total SLEDAI-2K score of at least 6 points and clinical SLEDAI-2K score of at least 4 points
At least one BILAG A or one BILAG B grade at screening with sufficient disease activity
On stable SLE background therapy with no more than one immunosuppressant and/or one antimalarial for at least 8 weeks
Oral corticosteroids at a dose of 30 mg/day prednisone or equivalent or less, stable for at least 2 weeks before screening

You will not qualify if you...

Drug-induced systemic lupus erythematosus
Scleroderma or other connective tissue diseases interfering with SLE assessment, except linear scleroderma not affecting evaluations
Active or unstable lupus neuropsychiatric symptoms defined by BILAG A criteria, except certain exceptions
Lupus nephritis requiring immune-modulating treatment changes or with unstable kidney function or abnormal protein levels
Oral corticosteroids above 30 mg/day prednisone or equivalent at screening

Research Team

Boehringer Ingelheim

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