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

NCT06636656 · tracked via the Priya Life Science USA tracker

Sponsor

Boehringer Ingelheim

Phase

Phase 2

Started

2024-12-11

Last updated

2026-08-21

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

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

BI 3032950 intravenous (Part A): BI 3032950 intravenous (Part A)

BI 3032950 subcutaneous (Part B): BI 3032950 subcutaneous (Part B)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

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 — 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.

Trial sites (41)

Facility	City	Region	Status
One of a Kind Clinical Research Center	Scottsdale	Arizona	Not Yet Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	Recruiting
Primary Care of Osceola	Kissimmee	Florida	Not Yet Recruiting
Florida Research Institute	Lakewood Rch	Florida	Recruiting
University of Miami	Miami	Florida	Recruiting
Reliant Medical Research	Miami	Florida	Recruiting
Illinois Gastroenterology Group - Gurnee	Gurnee	Illinois	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
Columbia University Medical Center	New York	New York	Not Yet Recruiting
Atrium Health Gastroenterology and Hepatology	Charlotte	North Carolina	Recruiting
Texas Digestive Disease Consultants	Cedar Park	Texas	Recruiting
Baylor College of Medicine	Houston	Texas	Recruiting
University of Washington	Seattle	Washington	Not Yet Recruiting
Digestive Health Specialists	Tacoma	Washington	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
CHC MontLegia	Liège	Belgium	Recruiting
Hepato-Gastroenterologie HK, s.r.o.	Hradec Králové	Czechia	Not Yet Recruiting
ISCARE a.s.	Prague	Czechia	Recruiting
Centrum Medyczne Plejady	Krakow	Poland	Recruiting
Medrise Sp. z o.o.	Lublin	Poland	Recruiting
Eskulap Pabianice Sp. z o.o.	Pabianice	Poland	Recruiting
EMC Instytut Medyczny S.A. - Poznan 70-304	Poznan	Poland	Recruiting
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland	Recruiting
Centrum Medyczne Medyk Sp. z o.o.	Rzeszów	Poland	Recruiting
Endoskopia Sp. z o.o.	Sopot	Poland	Recruiting
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland	Recruiting
Gastromed Sp. z o.o.	Torun	Poland	Recruiting
Synexus Polska Sp. z o.o.	Warsaw	Poland	Recruiting
NZOZ VIVAMED Jadwiga Miecz	Warsaw	Poland	Recruiting
PlanetMed Sp. z o.o.	Wroclaw	Poland	Recruiting
EMC Instytut Medyczny S.A. - Wroclaw	Wroclaw	Poland	Recruiting
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.	Włocławek	Poland	Recruiting
Pro Life Medica Sp. z o.o.	Zamość	Poland	Recruiting
Clinical Hospital Center Zvezdara	Belgrade	Serbia	Recruiting
Military Medical Academy	Belgrade	Serbia	Not Yet Recruiting
Clinical Center Zemun	Belgrade	Serbia	Not Yet Recruiting
General Hospital - Djordje Joanovic	Zrenjanin	Serbia	Recruiting
F D Roosevelt University General Hospital Of Banska Bystrica	Banská Bystrica	Slovakia	Recruiting
ENDOMED s.r.o.	Košice	Slovakia	Recruiting
KM Management, spol. s.r.o.	Nitra	Slovakia	Recruiting

+ 1 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06636656 on ClinicalTrials.gov ↗ ← All trials in the USA