Clinical Trial TitleA Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease
National Clinical Trial Number:NCT04978493
Clinical Trial Protocol Description:
This is a randomized, double-blind, clinical trial designed with the purpose to determine if combining BI 706321 with Ustekinumab, an already established treatment of Crohn's disease, helps patients with Crohn's disease. A description of this clinical trial will be available at www.ClinicalTrials.gov, as required by U.S. law.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 to 75 years of age.
- Have been diagnosed with Crohn's Disease for at least 3 months.
- Have symptomatic Crohn's Disease defined as Crohn's Disease Activity Index (CDAI) ≥150.
You will be excluded from the study if any of the following criteria apply to you:
- Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to randomization and are not anticipated to require surgery.
- Have complications of Crohn's Disease such as strictures, stenosis, short bowel syndrome, or any other manifestation that might require surgery.
- Have an inflammatory bowel disease (IBD) diagnosis other than Crohn's.
- Have had any kind of bowel resection or diversion within 4 months or any other intra-abdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.