Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Phase IIa, Sequential Cohort, 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

A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis (NCT06636656) is a Phase 2 interventional studying Ulcerative Colitis, sponsored by Boehringer Ingelheim. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis. This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years. Participants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body. The doctors also regularly check participants' health and take note of any unwanted effects.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ulcerative Colitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ulcerative Colitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion criteria - Female and male participants aged 18 to 80 years (inclusive) at the time of willing to sign a consent form, - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

BI 3032950 intravenous (Part A)

DRUG

BI 3032950 subcutaneous (Part B)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

One of a Kind Clinical Research Center

Scottsdale, Arizona, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

University of Miami

Miami, Florida, United States

Reliant Medical Research

Miami, Florida, United States

Illinois Gastroenterology Group - Gurnee

Gurnee, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Columbia University Medical Center

New York, New York, United States

Atrium Health Gastroenterology and Hepatology

Charlotte, North Carolina, United States

Texas Digestive Disease Consultants

Cedar Park, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Digestive Health Specialists

Tacoma, Washington, United States

UZ Leuven

Leuven, Belgium

CHC MontLegia

Liège, Belgium

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

ISCARE a.s.

Prague, Czechia

Centrum Medyczne Plejady

Krakow, Poland

Medrise Sp. z o.o.

Lublin, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06636656), the sponsor (Boehringer Ingelheim), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06636656 clinical trial studying?

Who can participate in NCT06636656?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06636656?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT06636656. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06636656. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.