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

This study is for adults aged 18 to 80 who have ulcerative colitis (a chronic inflammatory bowel disease) and whose previous treatments haven't worked well or were stopped. We are testing a drug called BI 3032950 to see if it can help improve symptoms. The study has two parts. In Part A, you would receive BI 3032950 intravenously (through a vein) every four weeks. After 12 weeks, doctors will check if your symptoms have improved. You would then move to Part B, where BI 3032950 is given as an injection under the skin. If your symptoms show improvement after 12 weeks, you may continue receiving BI 3032950. The main goal is to see how many people achieve clinical remission (a significant reduction in symptoms) by week 12.

Study design: This is an interventional study planning to enroll 80 participants. It involves two parts where BI 3032950 is given either intravenously or subcutaneously.
What's involved: In Part A, participants receive BI 3032950 intravenously every 4 weeks. After 12 weeks, participants move to Part B and receive BI 3032950 as an injection under the skin.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome for symptom improvement is measured up to Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE2Ages 18–80InterventionalTreatment

Boehringer Ingelheim

~80 participants

Updated 2026-08-21 on ClinicalTrials.gov

What's tested:BI 3032950 intravenous (Part A)BI 3032950 subcutaneous (Part B)

At a glance

Recruiting sites

34 of 41 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1

Measured over Up to Week 12

Conditions

Ulcerative Colitis

Where it's being run

41 sites across 14 states

Poland15

Florida4

Serbia4

Slovakia4

Texas2

Washington2

Belgium2

Czechia2

Who to contact

Boehringer Ingelheim

[email protected]

1-800-243-0127

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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,

Exclusion

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,

What this trial measures

Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1Up to Week 12
The modified Mayo score (mMS) consists of 3 components 1. Stool frequency subscore (SFS) 2. Rectal bleeding subscore (RBS) 3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.

Trialytics