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

August 19, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Pabianice, Poland, 95-200
        • 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
        • Recruiting
        • Centrum Medyczne Medyk Sp. z o.o.
        • Contact:
      • Sopot, Poland, 81-756
      • Szczecin, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
        • Contact:
      • Torun, Poland, 87-100
      • Warsaw, Poland, 02-672
        • Recruiting
        • Synexus Polska Sp. z o.o.
        • Contact:
      • Warsaw, Poland, 03-580
        • 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
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1486-0006
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 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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