In short
One authorised Phase 1/2a trial (NCT07412704) is currently evaluating its safety in 72 participants. The study also includes tocilizumab, an approved rheumatoid arthritis medicine given intravenously, as part of the treatment regimen.
Key points
- It is being studied in refractory rheumatoid arthritis, a form of the disease that has not responded well to other treatments.
- The only registered trial is a Phase 1/2a open-label study with 72 planned participants.
- The trial is currently authorised, meaning it has received regulatory approval to proceed.
- The main goal is to measure safety by counting mild and serious side effects after treatment.
What is BI 3821001?
In the clinical trial registry records, it appears as a test drug in a study for people with refractory rheumatoid arthritis, meaning rheumatoid arthritis that has not responded well to previous treatments. The substance has no marketing authorisation listed in these records, which means it is still being researched and is not yet approved as a medicine for general use.
The trial record also lists tocilizumab, an approved medicine for rheumatoid arthritis, as a separate drug in the study. The two substances are distinct arms of the same study.
How does BI 3821001 work?
No information is provided about its molecular target, whether it blocks or activates a specific pathway, or how it might affect the immune system in rheumatoid arthritis. The trial is designed primarily to assess safety rather than to confirm how the substance works.
How is BI 3821001 given?
The trial record does not state the dose, the frequency of injections, or the duration of treatment. Tocilizumab, the other drug in the study, is given intravenously, which means it is infused directly into a vein.
What do the clinical trials show?
It is a Phase 1/2a, open-label study, which means both the researchers and the participants know which treatment is being given. The trial is currently authorised, meaning it has received the necessary approvals to begin or continue. The planned number of participants is 72.
The primary outcome is safety. The trial record does not list any secondary outcomes, such as measures of how well the substance works against rheumatoid arthritis symptoms.
The study is interventional, meaning participants receive a treatment as part of the research. The record does not state the countries where the trial is taking place, the ages of participants who can take part, or the specific inclusion and exclusion criteria.
What side effects are known?
The trial is designed to collect this information, and its primary outcome is to count mild and serious side effects. No results from the study are available in the record.