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

Last updated: May 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Colic

Crohn's Disease

Ulcers

Treatment

BI 3032950 intravenous (Part A)

BI 3032950 subcutaneous (Part B)

Clinical Study ID

NCT06636656
1486-0006
2023-509544-10-00
U1111-1300-3640
  • Ages 18-80
  • All Genders

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 Criteria

Inclusion

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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: BI 3032950 intravenous (Part A)
Phase: 2
Study Start date:
December 11, 2024
Estimated Completion Date:
June 09, 2028

Connect with a study center

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Clinique CHC Montlégia

    Liège, 4000
    Belgium

    Active - Recruiting

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Kralove, 50012
    Czechia

    Site Not Available

  • University Hospital Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • ISCARE a.s.

    Praha 9, 190 00
    Czechia

    Active - Recruiting

  • Centrum Medyczne Medis

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30-363
    Poland

    Active - Recruiting

  • Eskulap Pabianice Sp. Z o.o.

    Lodz, 91-363
    Poland

    Site Not Available

  • Healthcare Center Gastromed - SCANMED GROUP

    Lublin, 20-582
    Poland

    Site Not Available

  • Medrise Sp. z o.o.

    Lublin, 20-582
    Poland

    Site Not Available

  • Clinical Research Center

    Poznan, 60-848
    Poland

    Active - Recruiting

  • Clinical Research Center Sp. z o.o. Medic-R sp. k.

    Poznan, 60-848
    Poland

    Active - Recruiting

  • EMC Instytut Medyczny S.A.-Poznan-70304

    Poznan, 60-309
    Poland

    Active - Recruiting

  • Medical Center Medyk

    Rzeszow, 35-326
    Poland

    Site Not Available

  • Endoskopia Sp. z o.o.

    Sopot, 81-756
    Poland

    Active - Recruiting

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Active - Recruiting

  • Gastromed Sp. z o.o.

    Torun, 87-100
    Poland

    Site Not Available

  • Non-Public Outpatient Medical Care VIVAMED, Warsaw

    Warsaw, 03-580
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o.

    Warszawa, 02-672
    Poland

    Active - Recruiting

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

    Wloclawek, 87-800
    Poland

    Site Not Available

  • EMC Instytut Medyczny S.A.-Wroclaw-70301

    Wroclaw, 54-144
    Poland

    Active - Recruiting

  • PlanetMed Sp. z o.o.

    Wroclaw, 52-210
    Poland

    Site Not Available

  • ETG Zamosc

    Zamosc, 22-400
    Poland

    Active - Recruiting

  • Clinical Center Zemun

    Belgrade, 11080
    Serbia

    Site Not Available

  • Clinical Hospital Center Dr. Dragisa Misovic

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Medical Center Zvezdara, Belgrade

    Belgrade, 11000
    Serbia

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Clinical Center of Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • General Hospital - Djordje Joanovic

    Zrenjanin, 23101
    Serbia

    Active - Recruiting

  • FNsP F.D.R. Banska Bystrica

    Banska Bystrica, 975 17
    Slovakia

    Site Not Available

  • ENDOMED s.r.o.

    Kosice, 040 13
    Slovakia

    Site Not Available

  • KM Management, spol. s.r.o.

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Gastro I., s.r.o

    Presov, 8001
    Slovakia

    Active - Recruiting

  • Accout Center s.r.o.

    Sahy, 93601
    Slovakia

    Site Not Available

  • Future Innovative Treatments

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Future Innovative Treatments, LLC

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Medical Research Center of Connecticut, LLC

    New Haven, Connecticut 06518-3691
    United States

    Site Not Available

  • Florida Research Institute

    Lakewood Ranch, Florida 34211
    United States

    Active - Recruiting

  • Medical Professional Clinical Research

    Miami, Florida 33165
    United States

    Site Not Available

  • Reliant Medical Research

    Miami, Florida 33165-3639
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Illinois Gastroenterology Group - Gurnee

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66103-2937
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032-3725
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28204-2963
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Texas Digestive Disease Consultants

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • GI Alliance

    Mansfield, Texas 76063
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195-0001
    United States

    Site Not Available

  • Digestive Health Specialists

    Tacoma, Washington 98405-2318
    United States

    Active - Recruiting

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