BI 706321 + Ustekinumab for Crohn's Disease
Trial Summary
Will I have to stop taking my current medications?
The trial allows participants to continue taking certain medications like oral 5-aminosalicylic acid, oral corticosteroids, azathioprine, mercaptopurine, or methotrexate, as long as the doses have been stable for a specified period before joining the study. However, other non-biologic medications for inflammatory bowel disease and certain biologic treatments must be stopped before participating.
What data supports the effectiveness of the drug Ustekinumab for Crohn's Disease?
Is the combination of BI 706321 and Ustekinumab safe for humans?
What makes the drug combination BI 706321 and Ustekinumab unique for treating Crohn's Disease?
The combination of BI 706321 and Ustekinumab is unique because it pairs a new investigational drug (BI 706321) with Ustekinumab, which is already known for its distinct mechanism of targeting specific proteins (IL-12 and IL-23) involved in inflammation, offering a novel approach for patients who have not responded to other treatments.126910
What is the purpose of this trial?
This trial is for adults with moderate to severe Crohn's disease. It tests if a new medicine, BI 706321, combined with ustekinumab, can help reduce symptoms. Participants take daily pills and receive regular injections, and their health is closely monitored. Ustekinumab is approved for the treatment of Crohn's disease and ulcerative colitis.
Eligibility Criteria
Adults aged 18-75 with moderate to severe Crohn's disease can join this trial. They must have a confirmed diagnosis for at least 3 months, active symptoms, and certain inflammation markers. Stable doses of specific medications are required, and women must use effective birth control. Exclusions include recent surgeries, other IBD diagnoses, untreated abscesses or infections like HIV or COVID-19.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BI 706321 or placebo in combination with ustekinumab for 3 months
Maintenance
Participants receive only ustekinumab for an additional 9 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BI 706321
- Placebo
- Ustekinumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor