A Phase 2 interventional study of BI 3000202 and Placebo in Systemic Lupus Erythematosus, sponsored by Boehringer Ingelheim. Recruiting at 140 sites in 21 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
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.
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.
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
Exclusion Criteria:
Drug: BI 3000202
Drug: BI 3000202
Drug: BI 3000202
Drug: BI 3000202
Drug: Placebo
BI 3000202 at different doses
Placebo matching BI 3000202
Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response
Time frame: At Week 32
Achievement of SRI-4 response
Time frame: At Week 52
Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent
Time frame: At Week 32
Achievement of Lupus Low Disease Activity State (LLDAS)
Time frame: At Week 32
Showing the first 100 of 140 sites across 21 countries.
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
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Lupus Erythematosus, Systemic→
Boehringer Ingelheim