In short
BI 3000202 is an investigational chemical substance being developed by Boehringer Ingelheim International. It is currently being tested in clinical trials for systemic lupus erythematosus (SLE), a chronic autoimmune disease. The substance has no marketing authorisation and is given as a film-coated tablet by mouth. Two trials are registered: a completed Phase 1 study in 68 healthy men and an authorised Phase 2 study in 216 people with moderate to severe SLE.
Key points
- BI 3000202 is an investigational chemical substance with no marketing authorisation.
- It is given as a film-coated tablet taken by mouth.
- The main condition being studied is systemic lupus erythematosus (SLE).
- A Phase 2 trial is authorised to test different doses in 216 people with moderate to severe SLE.
- A completed Phase 1 trial in 68 healthy men tested safety, tolerability, and how food affects the drug.
- The Phase 2 trial measures whether people achieve an SRI-4 response at Week 32.
What is BI 3000202?
BI 3000202 is a chemically synthesised substance classified as an investigational medicine. It has no marketing authorisation in the product records, meaning it is not yet approved as a medicine for patients outside of clinical trials. The substance is developed by Boehringer Ingelheim International. Its therapeutic area in the registry covers immune system diseases. BI 3000202 is the only name under which the substance appears in the product records.
How does BI 3000202 work?
The clinical trial records do not state a molecular target or mechanism of action for BI 3000202. The Phase 1 trial describes the substance as an investigational drug whose safety, tolerability, and pharmacokinetics are being studied, but no specific target is named in the available data. Pharmacokinetics refers to how a drug is absorbed, distributed, broken down, and removed by the body.
Which conditions is BI 3000202 used or studied for?
- Systemic lupus erythematosus (SLE) — a chronic autoimmune disease in which the immune system attacks healthy tissues. A Phase 2 trial is testing whether different doses of BI 3000202 help people with moderate to severe SLE.
- Healthy volunteer trial — a completed Phase 1 study in healthy men tested how well different doses are tolerated and how food influences the amount of drug in the blood.
How is BI 3000202 given?
BI 3000202 is given as a film-coated tablet taken by mouth. The pharmaceutical form in the product records is film-coated tablet, and the route of administration is oral use. In the Phase 1 trial, single doses of 3 mg, 10 mg, 25 mg, and 250 mg were tested in healthy men. The Phase 2 trial in SLE uses oral administration, but the specific doses are not reported in the registry record.
What do the clinical trials show?
Two trials of BI 3000202 are registered. One is a completed Phase 1 study in 68 healthy men, and the other is an authorised Phase 2 study in 216 people with moderate to severe SLE.
The Phase 1 trial had two parts. The single rising dose part investigated safety, tolerability, and pharmacokinetics after single doses. The food effect part investigated the relative bioavailability of BI 3000202, meaning how much of the drug reaches the bloodstream, and how food influences this. The main measures included the occurrence of any treatment-related adverse events, the maximum measured concentration of the drug in plasma (Cmax), and the area under the concentration-time curve over 24 hours (AUC0-24), which describes how much of the drug stays in the blood over time.
The Phase 2 trial aims to demonstrate a non-flat dose response curve and to evaluate the treatment effect of different dose regimens of BI 3000202 compared with placebo. The primary endpoint is the achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32. The SRI-4 is a composite measure used in lupus trials that captures improvement in disease activity without worsening in other key areas.
The Phase 2 trial is authorised but not yet recruiting, while the Phase 1 trial has been completed. Both trials are interventional studies in which BI 3000202 is the test substance.
What side effects are known?
The available registry data do not report side effects of BI 3000202. The Phase 1 trial measured treatment-emergent adverse events as a primary outcome, but the results are not included in the registry record. No supplementary source with side effect information was provided.