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

June 1, 2026 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
  • Czechia
      • Hradec Králové, Czechia, 500 12
        • Not yet recruiting
        • Hepato-gastroenterologie HK, s.r.o.
        • Contact:
      • Prague, Czechia, 190 00
  • Poland
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Contact:
      • Lublin, Poland, 20-582
        • Not yet recruiting
        • Medrise Sp. z o.o.
        • Contact:
      • Pabianice, Poland, 95-200
        • Not yet recruiting
        • Eskulap Pabianice Sp. z o.o.
        • Contact:
      • Poznan, Poland, 60-309
        • Recruiting
        • EMC Instytut Medyczny S.A. - Poznan 70-304
        • Contact:
      • Poznan, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z o.o. Medic-R sp.k.
        • Contact:
      • Rzeszów, Poland, 35-326
        • Not yet recruiting
        • Centrum Medyczne Medyk Sp. z o.o.
        • Contact:
      • Sopot, Poland, 81-756
      • Szczecin, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia Szczecińskie Centrum Medyczne Sp. z o.o.
        • Contact:
      • Torun, Poland, 87-100
        • Not yet recruiting
        • GASTROMED Sp. z o.o.
        • Contact:
      • Warsaw, Poland, 02-672
        • Recruiting
        • Synexus Polska Sp. z o.o.
        • Contact:
      • Warsaw, Poland, 03-580
        • Not yet recruiting
        • NZOZ VIVAMED Jadwiga Miecz
        • Contact:
      • Wroclaw, Poland, 52-210
      • Wroclaw, Poland, 54-239
        • Recruiting
        • EMC Instytut Medyczny S.A. - Wroclaw
        • Contact:
      • Włocławek, Poland, 87-800
        • Not yet recruiting
        • Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
        • Contact:
      • Zamość, Poland, 22-400
        • Recruiting
        • Pro Life Medica Sp. z o.o.
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11040
        • Not yet recruiting
        • Military Medical Academy
        • Contact:
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Hospital Center Zvezdara
        • Contact:
      • Belgrade, Serbia, 11080
        • Not yet recruiting
        • Clinical Center Zemun
        • Contact:
      • Zrenjanin, Serbia, 23101
        • Recruiting
        • General Hospital - Djordje Joanovic
        • Contact:
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Recruiting
        • F D Roosevelt University General Hospital Of Banska Bystrica
        • Contact:
      • Košice, Slovakia, 040 13
      • Nitra, Slovakia, 949 01
      • Prešov, Slovakia, 080 01
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Not yet recruiting
        • One of a Kind Clinical Research Center
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
    • Florida
      • Kissimmee, Florida, United States, 34741
      • Lakewood Rch, Florida, United States, 34211
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33165-3639
    • Illinois
      • Gurnee, Illinois, United States, 60031
    • Kansas
      • Kansas City, Kansas, United States, 66103-2937
    • New York
      • New York, New York, United States, 10032-3725
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-2963
    • Texas
      • Cedar Park, Texas, United States, 78613
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 98195-0001
      • Tacoma, Washington, United States, 98405-2318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: BI 3032950 intravenous (Part A)
BI 3032950 intravenous (Part A)
Drug: BI 3032950 subcutaneous (Part B)
BI 3032950 subcutaneous (Part B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic remission (defined as centrally-read ESS of 0)
Time Frame: Up to Week 12
The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Up to Week 12
Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)
Time Frame: 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.
Up to Week 12
Endoscopic improvement (defined as centrally-read ESS of 0 or 1)
Time Frame: Up to Week 12
The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Up to Week 12
Modified Mayo Score change from baseline
Time Frame: 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.
Up to Week 12
Stool frequency subscore of 0 or 1
Time Frame: Up to Week 12
The stool frequency (SFS) is graded from 0 = none to 3 = severe. The SFS is part of the modified Mayo score.
Up to Week 12
Rectal bleeding subscore of 0
Time Frame: Up to Week 12
The rectal bleeding subscore (RBS) is graded from 0 = none to 3 = severe. The RBS is part of the modified Mayo score.
Up to Week 12
Occurrence of treatment-emergent adverse events (AEs)
Time Frame: Up to Week 12 and up to Week 104
Up to Week 12 and up to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2024

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1486-0006
  • 2023-509544-10-00 (Registry Identifier: CTIS (EU))
  • U1111-1300-3640 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a "Document Sharing Agreement". For study data -

  1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan);
  2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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