A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis

Launched by BOEHRINGER INGELHEIM · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BI 3032950 to see if it can help people with ulcerative colitis, a condition that causes inflammation in the digestive tract. Adults aged 18 to 80 who have not had success with previous treatments or had to stop their treatment may be eligible to participate. To join, participants must have been diagnosed with ulcerative colitis at least three months before the study and must be willing to follow certain guidelines regarding birth control if they are of childbearing age.

Participants in the trial will go through two parts. In the first part, they will receive BI 3032950 as an infusion into a vein every four weeks for 12 weeks, after which the doctors will assess their condition. If they show improvement, they will continue to receive the treatment as an injection under the skin for up to two years. Throughout the study, participants will have regular check-ups every four weeks, where doctors will monitor their symptoms and overall health, including some tests and procedures to look inside the body. The study is currently recruiting participants, and it's important for those interested to discuss with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
• • Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
• • Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
• • Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
• • Further inclusion criteria apply.
• • Exclusion criteria
• • Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
• • Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
• • Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
• • Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
• • Evidence of fulminant colitis or toxic megacolon at screening,
• • Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
• • Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
• • Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
• • Further exclusion criteria apply.