RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT06636656

Registry updated: 2026-08-21

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Description

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.

Interventions

BI 3032950 intravenous (Part A) (Drug)
BI 3032950 intravenous (Part A)
BI 3032950 subcutaneous (Part B) (Drug)
BI 3032950 subcutaneous (Part B)

Eligibility 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.

Conditions

Ulcerative Colitis

Locations

One of a Kind Clinical Research Center — Scottsdale, Arizona, United States
Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
Primary Care 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
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 — Wroclaw, Poland
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. — Włocławek, Poland
Pro Life Medica Sp. z o.o. — Zamość, Poland
Clinical Hospital Center Zvezdara — Belgrade, Serbia
Military Medical Academy — Belgrade, Serbia
Clinical Center Zemun — Belgrade, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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