Under construction – not a live service
Sign in
Taking people in SerbiaPhase 2

Testing BI 3032950 for People With Ulcerative Colitis

Tests BI 3032950, given by infusion then injection, in adults with ulcerative colitis.

Key facts

Who runs it
Boehringer Ingelheim
Where
Belgrade and Zrenjanin, SerbiaSee the 4 sitesAlso in 5 other countries, 38 sites
Trial code
Registry title
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Status
Recruiting
Phase
Phase 2
People taking part
80 people, planned
Started
11 Dec 2024
Expected to end
30 Jul 2029
Type of study
Interventional
Treatments tested
  • BI 3032950 intravenous (Part A)
  • BI 3032950 subcutaneous (Part B)
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ulcerative colitis, a long-term bowel disease. Earlier treatment with a biologic or targeted therapy did not work well enough, was not tolerated, or was stopped.

Age
18 to 80 years
Sex
Women and men can join.
Disease stage
Ulcerative colitis diagnosed at least 3 months before screening, confirmed by clinical and endoscopic findings and a histopathology report. The trial title says moderate to severe.
Earlier treatment
Earlier biologic or targeted therapy did not work well enough, the response was lost, it was not tolerated, or the treatment was stopped for another reason.

Main reasons for not taking part

  • Other types of colitis, such as indeterminate, ischemic, radiation or microscopic colitis, or Crohn's disease
  • Signs that suggest Crohn's disease, such as fistulae or granulomas on biopsy
  • Fulminant colitis or toxic megacolon at screening
  • Gastrointestinal neoplasia, primary sclerosing cholangitis or a known colonic stricture
  • Previous or planned surgery for ulcerative colitis (may be allowed after the investigator's judgement)

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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,
  • 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,
  • Further exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in Serbia

Also in 5 other countries, 38 sites

  • Clinical Center ZemunBelgrade, SerbiaContact: Boehringer IngelheimNot yet recruiting
  • Clinical. Hospital Center ZvezdaraBelgrade, SerbiaContact: Boehringer IngelheimTaking people
  • Military Medical AcademyBelgrade, SerbiaContact: Boehringer IngelheimNot yet recruiting
  • General Hospital - Djordje JoanovicZrenjanin, SerbiaContact: Boehringer IngelheimTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • All participantsTreatment being tested

    All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.

    Treatment: BI 3032950 intravenous (Part A) and BI 3032950 subcutaneous (Part B)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing BI 3032950 for People With Ulcerative ColitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06636656, who can take part
Record updated
12 November 2026