Testing BI 3032950 for Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of BI 3032950 in adults aged 18 to 80 with ulcerative colitis who have not responded to previous treatments. Participants will receive BI 3032950 through intravenous infusion every four weeks for 12 weeks, followed by subcutaneous injections if they show clinical response. The study includes regular doctor visits to monitor symptoms and collect blood and stool samples. The goal is to determine if this new treatment can improve the condition of patients with ulcerative colitis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peak Gastroenterology Associates
  Colorado Springs, Colorado, United States Recruiting
• Florida Research Institute
  Lakewood Rch, Florida, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Reliant Medical Research
  Miami, Florida, United States Recruiting
• Illinois Gastroenterology Group - Gurnee
  Gurnee, Illinois, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.