A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Boehringer Ingelheim · NCT06636656
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 80
- US sites recruiting
- 10
- Study start
- December 11, 2024
- Record last updated
- August 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: BI 3032950 intravenous (Part A); BI 3032950 subcutaneous (Part B)
Conditions: Ulcerative Colitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Peak Gastroenterology Associates
Colorado Springs, CO 80907
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Florida Research Institute
Lakewood Rch, FL 34211
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Miami
Miami, FL 33136
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Reliant Medical Research
Miami, FL 33165-3639
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Illinois Gastroenterology Group - Gurnee
Gurnee, IL 60031
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Kansas Medical Center
Kansas City, KS 66103-2937
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Atrium Health Gastroenterology and Hepatology
Charlotte, NC 28204-2963
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Texas Digestive Disease Consultants
Cedar Park, TX 78613
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Baylor College of Medicine
Houston, TX 77030
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Digestive Health Specialists
Tacoma, WA 98405-2318
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Study contacts (from the official record)
- Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com