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NCT06636656RecruitingPhase 2

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

Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
7 Oct 2024
Start date
11 Dec 2024
Primary completion date
30 Jul 2027
Lead sponsor
Boehringer Ingelheim
NCT number
NCT06636656
EU CT number
2023-509544-10-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • From 11 Dec 2024 to the primary completion date, 30 Jul 2027
  • 41 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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,

Other illness

  • Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),

Other

  • 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,
  • Further exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
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LeuvenBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Hepato-Gastroenterologie HK, s.r.o.
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaNot yet recruiting
ISCARE a.s.
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PragueCzechiaRecruiting
Centrum Medyczne Plejady
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KrakowPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
Eskulap Pabianice Sp. z o.o.
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PabianicePolandRecruiting
EMC Instytut Medyczny S.A. - Poznan 70-304
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PoznanPolandRecruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandRecruiting
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandRecruiting
Endoskopia Sp z o.o.
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SopotPolandRecruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
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SzczecinPolandRecruiting
GASTROMED Sp. z o.o.
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TorunPolandRecruiting
Synexus Polska Sp. z o.o.
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WarsawPolandRecruiting
NZOZ VIVAMED Jadwiga Miecz
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WarsawPolandRecruiting
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
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WłocławekPolandRecruiting
PlanetMed Sp. z o.o.
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WroclawPolandRecruiting
EMC Instytut Medyczny S.A. - Wroclaw
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WroclawPolandRecruiting
Pro Life Medica Sp. z o.o.
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ZamośćPolandRecruiting
Clinical. Hospital Center Zvezdara
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BelgradeSerbiaRecruiting
Clinical Center Zemun
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BelgradeSerbiaNot yet recruiting
Military Medical Academy
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BelgradeSerbiaNot yet recruiting
General Hospital - Djordje Joanovic
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ZrenjaninSerbiaRecruiting
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaRecruiting
ENDOMED, s.r.o.
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KošiceSlovakiaRecruiting
KM Management spol. s r.o.
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NitraSlovakiaRecruiting
GASTRO I., s.r.o.
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PrešovSlovakiaRecruiting
Texas Digestive Disease Consultants
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Cedar ParkUnited StatesRecruiting
Atrium Health Gastroenterology and Hepatology
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CharlotteUnited StatesRecruiting
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesRecruiting
Illinois Gastroenterology Group - Gurnee
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GurneeUnited StatesRecruiting
Baylor College of Medicine
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HoustonUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
Primary Care of Osceola
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KissimmeeUnited StatesNot yet recruiting
Florida Research Institute
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Lakewood RchUnited StatesRecruiting
University of Miami
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MiamiUnited StatesRecruiting
Reliant Medical Research
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MiamiUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesNot yet recruiting
One of a Kind Clinical Research Center
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ScottsdaleUnited StatesNot yet recruiting
University of Washington
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SeattleUnited StatesNot yet recruiting
Digestive Health Specialists
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TacomaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.