~11 spots leftby Feb 2026

BI 706321 + Ustekinumab for Crohn's Disease

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Boehringer Ingelheim
Prior Safety Data

Trial Summary

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

My Crohn's disease is active, with a CDAI score of 150 or more.
I have Crohn's disease with ulcers in my intestines and a high severity score.
I am on a stable dose of oral corticosteroids for my condition, not exceeding the specified limits.

Exclusion Criteria

I have been diagnosed with an inflammatory bowel disease that is not Crohn's disease.
I have not had recent major abdominal surgery or currently have a stoma.
I have been treated with ustekinumab before.
I have not taken experimental drugs for Crohn's disease.
I have had severe colon issues or growths, unless they were successfully removed.
I have not received any live vaccines in the last 4 weeks.
My heart's electrical activity (QT interval) is longer than normal.

Treatment Details

The study tests if BI 706321 combined with ustekinumab is beneficial for Crohn's disease treatment compared to ustekinumab alone. Participants will take BI 706321 or placebo tablets daily plus an initial infusion followed by injections of ustekinumab every two months over a year.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 706321 + ustekinumabExperimental Treatment2 Interventions
Group II: Placebo + ustekinumabPlacebo Group2 Interventions

Find a clinic near you

Research locations nearbySelect from list below to view details:
Clinical Research Inst of MIChesterfield, MI
Atlanta Center for Gastroenterology, P.C.Decatur, GA
Morehouse School of MedicineAtlanta, GA
Advanced Research Institute, Inc.Orlando, FL
More Trial Locations
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Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

References