Ulcerative Colitis
BI 3032950 for Adults With Moderate to Severe Ulcerative Colitis
This phase 2 study is investigating the effects and safety of intravenous followed by under-the-skin BI 3032950 in adults with ulcerative colitis whose previous biologic or targeted treatment was unsuccessful, stopped working, was not tolerated, or was discontinued.
Registry title: A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
14 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- BI 3032950 intravenous (Part A) or BI 3032950 subcutaneous (Part B)
- Design
- Not provided
- Central study contact
- Boehringer Ingelheim1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
- Sponsor
- Boehringer Ingelheim
Research question
What effects does intravenous induction followed by under-the-skin maintenance treatment with BI 3032950 have on ulcerative colitis remission, symptoms, endoscopic findings, and adverse events?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- The study is looking for people with ulcerative colitis diagnosed at least three months before screening and supported by clinical, endoscopic, and pathology evidence.
- The study is looking for people whose biologic or targeted therapy was inadequate, stopped working, was not tolerated, or was ended for another reason.
- Study locations are listed in the United States, Belgium, Czechia, Poland, Serbia, and Slovakia, with site recruitment status varying by location.
Participation overview
What participation may involve
Participants receive BI 3032950 by intravenous infusion in Part A and then by injection under the skin in Part B. Continued Part B treatment depends on the 12-week clinical-response assessment. What participation may involve: - Receive an infusion of BI 3032950 into a vein every four weeks during Part A. - Receive BI 3032950 injections under the skin during Part B; participants with a clinical response after 12 weeks may continue injections every four weeks. - Attend doctor visits where ulcerative colitis signs and symptoms are checked. - Provide blood and stool samples and undergo endoscopies. - Have general health and unwanted effects checked regularly. Part A includes a clinical-response assessment after 12 weeks. Participants with a response may continue Part B injections for up to two years; the record does not state the full duration including screening and follow-up. The registry states that participants visit their doctors every four weeks, but it does not provide a complete visit schedule.
Study interventions
What participants may receive or do
- BI 3032950 intravenous (Part A): In Part A, all participants receive BI 3032950 through an infusion into a vein every four weeks. The registry describes an assessment after 12 weeks.
- BI 3032950 subcutaneous (Part B): In Part B, all participants initially receive BI 3032950 by injection under the skin. Participants showing a clinical response after 12 weeks can continue injections every four weeks for up to two years.
Study design
How the comparison works
This is an open-label phase 2 study in which all participants follow the same sequence: intravenous BI 3032950 in Part A followed by under-the-skin BI 3032950 in Part B. The registry marks allocation as not applicable and does not describe random assignment. The study is open-label, meaning the registry reports no masking. The registry lists one experimental arm containing all participants and no separate comparison group. No placebo or sham intervention is listed in the registry record.
Reported activities
Procedures and tests
- Intravenous infusions of BI 3032950 during Part A.
- Under-the-skin injections of BI 3032950 during Part B.
- Blood sample collection during study visits.
- Stool sample collection during study visits.
- Endoscopies to examine the inside of the bowel.
- Assessment of stool frequency, rectal bleeding, and endoscopic findings using the modified Mayo Score.
- Regular checks of ulcerative colitis signs and symptoms.
- Regular health checks and recording of unwanted effects.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 80 years old when they give informed consent.
- Ulcerative colitis must have been diagnosed at least three months before screening.
- The diagnosis must be supported by clinical and endoscopic evidence and a pathology report.
- A previous biologic or targeted therapy must have been inadequate, stopped working, not been tolerated, or been ended for another reason.
- Participants who could become pregnant must use highly effective birth control, and male participants must use condoms.
Possible reasons someone may not be able to join
- People are excluded for indeterminate, ischemic, radiation, diverticular-associated, or microscopic colitis, or for Crohn's disease.
- Findings suggesting Crohn's disease, such as fistulas or granulomas on biopsy, are exclusionary.
- Moderate or severe colon-lining dysplasia or colon adenomas are exclusionary unless the adenomas were properly removed.
- Gastrointestinal cancer, primary sclerosing cholangitis, or a known narrowing of the colon is exclusionary.
- Evidence of fulminant colitis or toxic megacolon at screening is exclusionary.
- A current ileal-pouch anal connection, ileostomy, colostomy, or known fixed symptomatic intestinal narrowing is exclusionary.
- Previous or anticipated ulcerative colitis surgery is generally exclusionary, although some previous colon surgery may be allowed after investigator and sponsor review.
- A current or previous abscess is exclusionary unless it was drained and treated at least six weeks before the first study-drug dose and is not expected to need surgery.
Important unknowns
What the record does not make clear
- The registry reports a 12-week assessment and maintenance injections for up to two years but does not state the complete duration including screening and follow-up.
- Endoscopies are reported, but their number, timing, preparation, sedation, and biopsy requirements are not specified.
- The record does not explain which current ulcerative colitis treatments may continue during the study.
- The record does not provide medication washout rules or timing.
- The record does not describe rescue treatment if ulcerative colitis worsens or does not respond.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether transportation, lodging, meals, or other travel expenses are supported.
- The record does not describe access to BI 3032950 after study treatment ends.
- The overall study is recruiting, but individual listed locations are either recruiting or not yet recruiting; current openings must be confirmed with the selected site.
Before contacting the site
Questions for the study team
- What is the complete schedule for screening, treatment, and follow-up, including the length of each visit?
- How many endoscopies are required, and what preparation, sedation, and biopsies do they involve?
- How is clinical response at 12 weeks determined, and what happens if I do not meet that definition?
- Which current ulcerative colitis medicines can continue, and which must be stopped or washed out?
- What treatment or medical support is available if my ulcerative colitis worsens during the study?
- Which study and routine-care costs are covered, and is compensation or travel support available?
- What safety monitoring occurs between the every-four-week visits, and whom should I contact about urgent symptoms?
- Is my preferred location and the relevant study cohort currently accepting participants?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what risks could arise if my current treatment changes for screening or study participation?
- What approved treatment alternatives remain appropriate for my disease history, and how do their known benefits and risks compare with the uncertainties of a phase 2 study?
- Are the study's repeated infusions, injections, blood and stool sampling, and endoscopies medically reasonable in my situation?
- Do my disease pattern, prior surgery, abscess history, colon findings, or other conditions need special review before I contact the study team?
- How should my regular gastroenterology care and urgent flare management be coordinated with the research team if I pursue screening?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Boehringer Ingelheim
- Organization class
- Industry
- Organization study ID
- 1486-0006
- Lead sponsor
- Boehringer Ingelheim
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Sequential
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
All participants
All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.
Interventions: Drug: BI 3032950 intravenous (Part A), Drug: BI 3032950 subcutaneous (Part B)
Interventions
Drug
BI 3032950 intravenous (Part A)
BI 3032950 intravenous (Part A)
Drug
BI 3032950 subcutaneous (Part B)
BI 3032950 subcutaneous (Part B)
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (4)
- Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,Registry-derived · unreviewed
- Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,Registry-derived · unreviewed
- 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,Registry-derived · unreviewed
- 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,Registry-derived · unreviewed
Exclusion criteria (8)
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),Registry-derived · unreviewed
- Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),Registry-derived · unreviewed
- Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,Registry-derived · unreviewed
- Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,Registry-derived · unreviewed
- Evidence of fulminant colitis or toxic megacolon at screening,Registry-derived · unreviewed
- Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,Registry-derived · unreviewed
- 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),Registry-derived · unreviewed
- 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,Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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
Time frame: Up 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.
Secondary outcome
Endoscopic remission (defined as centrally-read ESS of 0)
Time frame: Up to Week 12
The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Secondary outcome
Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)
Time frame: Up 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.
Secondary outcome
Endoscopic improvement (defined as centrally-read ESS of 0 or 1)
Time frame: Up to Week 12
The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Secondary outcome
Modified Mayo Score change from baseline
Time frame: Up 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.
Secondary outcome
Stool frequency subscore of 0 or 1
Time frame: Up to Week 12
The stool frequency (SFS) is graded from 0 = none to 3 = severe. The SFS is part of the modified Mayo score.
Secondary outcome
Rectal bleeding subscore of 0
Time frame: Up to Week 12
The rectal bleeding subscore (RBS) is graded from 0 = none to 3 = severe. The RBS is part of the modified Mayo score.
Secondary outcome
Occurrence of treatment-emergent adverse events (AEs)
Time frame: Up to Week 12 and up to Week 104
Recruiting locations in the United States
One of a Kind Clinical Research Center
Not Yet RecruitingScottsdale, Arizona, 85258, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Primary Care of Osceola
Not Yet RecruitingKissimmee, Florida, 34741, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Florida Research Institute
RecruitingLakewood Rch, Florida, 34211, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Reliant Medical Research
RecruitingMiami, Florida, 33165-3639, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of Miami
RecruitingMiami, Florida, 33136, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Illinois Gastroenterology Group - Gurnee
RecruitingGurnee, Illinois, 60031, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of Kansas Medical Center
RecruitingKansas City, Kansas, 66103-2937, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Columbia University Medical Center
Not Yet RecruitingNew York, New York, 10032-3725, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Atrium Health Gastroenterology and Hepatology
RecruitingCharlotte, North Carolina, 28204-2963, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Texas Digestive Disease Consultants
RecruitingCedar Park, Texas, 78613, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Baylor College of Medicine
RecruitingHouston, Texas, 77030, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of Washington
Not Yet RecruitingSeattle, Washington, 98195-0001, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Digestive Health Specialists
RecruitingTacoma, Washington, 98405-2318, United States
Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
This study also lists 27 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Oct 15, 2024
- Primary completion
- Jul 30, 2027
- Overall completion
- Jul 30, 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.