A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
NCT ID: NCT06636656
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-12-11
2028-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
BI 3032950 intravenous (Part A)
BI 3032950 intravenous (Part A)
BI 3032950 subcutaneous (Part B)
BI 3032950 subcutaneous (Part B)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BI 3032950 intravenous (Part A)
BI 3032950 intravenous (Part A)
BI 3032950 subcutaneous (Part B)
BI 3032950 subcutaneous (Part B)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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,
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Charlotte, North Carolina, United States
Texas Digestive Disease Consultants
Cedar Park, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
GI Alliance
Mansfield, Texas, United States
University of Washington
Seattle, Washington, United States
Digestive Health Specialists
Tacoma, Washington, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Az Maria Middelares Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHC MontLegia
Liège, , Belgium
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
University Hospital Ostrava
Ostrava, , Czechia
ISCARE a.s.
Prague, , Czechia
Centrum Medyczne Plejady
Krakow, , Poland
Medrise Sp. z o.o.
Lublin, , Poland
Eskulap Pabianice Sp. z o.o.
Pabianice, , Poland
EMC Instytut Medyczny S.A. - Poznan 70-304
Poznan, , Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Poznan, , Poland
Centrum Medyczne Medyk Sp. z o.o.
Rzeszów, , Poland
Endoskopia Sp. z o.o.
Sopot, , Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Szczecin, , Poland
Gastromed Sp. z o.o.
Torun, , Poland
Synexus Polska Sp. z o.o.
Warsaw, , Poland
NZOZ VIVAMED Jadwiga Miecz
Warsaw, , Poland
PlanetMed Sp. z o.o.
Wroclaw, , Poland
EMC Instytut Medyczny S.A. - Wroclaw 54-144
Wroclaw, , Poland
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
Włocławek, , Poland
Pro Life Medica Sp. z o.o.
Zamość, , Poland
Clinical Hospital Center Dr. Dragisa Misovic
Belgrade, , Serbia
Clinical Hospital Center Zvezdara
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Zemun
Belgrade, , Serbia
University Clinical Center of Kragujevac
Kragujevac, , Serbia
General Hospital - Djordje Joanovic
Zrenjanin, , Serbia
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, , Slovakia
ENDOMED s.r.o.
Košice, , Slovakia
KM Management, spol. s.r.o.
Nitra, , Slovakia
Gastro I., s.r.o
Prešov, , Slovakia
Accout Center s.r.o.
Šahy, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1486-0006
Identifier Type: -
Identifier Source: org_study_id
2023-509544-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1300-3640
Identifier Type: REGISTRY
Identifier Source: secondary_id