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Testing BI 3032950 for Ulcerative Colitis

Phase IIa, Single-arm, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis

PHASE2 · Boehringer Ingelheim · NCT06636656

This study is testing a new treatment called BI 3032950 to see if it can help adults with ulcerative colitis who haven't found relief from other treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBoehringer Ingelheim (industry)
Drugs / interventionsradiation
Locations50 sites (Colorado Springs, Colorado and 49 other locations)
Trial IDNCT06636656 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of ulcerative colitis who have had inadequate responses to previous biologic or targeted therapies.

Not a fit: Patients with other forms of colitis, such as Crohn's disease or indeterminate colitis, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with ulcerative colitis who have not benefited from existing therapies.

How similar studies have performed: Other studies have explored treatments for ulcerative colitis, but the specific approach of BI 3032950 is novel and has not been widely tested.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Colorado Springs, Colorado and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ulcerative Colitis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.