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NCT06636656PHASE2Recruiting

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

Boehringer Ingelheim

Start Date

12/11/2024

Completion Date

7/30/2029

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

Age Range: 18 years to 80 years

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.

Interventions

DRUG

BI 3032950 intravenous (Part A)

DRUG

BI 3032950 subcutaneous (Part B)

Interested in This Trial?

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Conditions

Ulcerative Colitis

Locations

One of a Kind Clinical Research Center

Scottsdale, Arizona 85258

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Clinical Research of Osceola

Kissimmee, Florida 34741

United States

Florida Research Institute

Lakewood Rch, Florida 34211

United States

University of Miami

Miami, Florida 33136

United States

Reliant Medical Research

Miami, Florida 33165-3639

United States

Illinois Gastroenterology Group - Gurnee

Gurnee, Illinois 60031

United States

University of Kansas Medical Center

Kansas City, Kansas 66103-2937

United States

Columbia University Medical Center

New York, New York 10032-3725

United States

Atrium Health Gastroenterology and Hepatology

Charlotte, North Carolina 28204-2963

United States

Texas Digestive Disease Consultants

Cedar Park, Texas 78613

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Washington

Seattle, Washington 98195-0001

United States

Digestive Health Specialists

Tacoma, Washington 98405-2318

United States

UZ Leuven

Leuven, 3000

Belgium

CHC MontLegia

Liège, 4000

Belgium

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12

Czechia

ISCARE a.s.

Prague, 190 00

Czechia

Centrum Medyczne Plejady

Krakow, 30-363

Poland

Medrise Sp. z o.o.

Lublin, 20-582

Poland

Eskulap Pabianice Sp. z o.o.

Pabianice, 95-200

Poland

EMC Instytut Medyczny S.A. - Poznan 70-304

Poznan, 60-309

Poland

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

Poznan, 61-731

Poland

Centrum Medyczne Medyk Sp. z o.o.

Rzeszów, 35-326

Poland

Endoskopia Sp. z o.o.

Sopot, 81-756

Poland

Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.

Szczecin, 71-434

Poland

Gastromed Sp. z o.o.

Torun, 87-100

Poland

Synexus Polska Sp. z o.o.

Warsaw, 02-672

Poland

NZOZ VIVAMED Jadwiga Miecz

Warsaw, 03-580

Poland

PlanetMed Sp. z o.o.

Wroclaw, 52-210

Poland

EMC Instytut Medyczny S.A. - Wroclaw

Wroclaw, 54-239

Poland

Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.

Włocławek, 87-800

Poland

Pro Life Medica Sp. z o.o.

Zamość, 22-400

Poland

Clinical Hospital Center Zvezdara

Belgrade, 11000

Serbia

Military Medical Academy

Belgrade, 11040

Serbia

Clinical Center Zemun

Belgrade, 11080

Serbia

General Hospital - Djordje Joanovic

Zrenjanin, 23101

Serbia

F D Roosevelt University General Hospital Of Banska Bystrica

Banská Bystrica, 975 17

Slovakia

ENDOMED s.r.o.

Košice, 040 13

Slovakia

KM Management, spol. s.r.o.

Nitra, 949 01

Slovakia

Gastro I., s.r.o

Prešov, 080 01

Slovakia