Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06636656
PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: Phase IIa, Single-arm, 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-12-11

Completion Date

2028-02-29

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

BI 3032950 intravenous (Part A)

BI 3032950 intravenous (Part A)

DRUG

BI 3032950 subcutaneous (Part B)

BI 3032950 subcutaneous (Part B)

Locations (41)

One of a Kind Clinical Research Center

Scottsdale, Arizona, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

University of Miami

Miami, Florida, United States

Reliant Medical Research

Miami, Florida, United States

Illinois Gastroenterology Group - Gurnee

Gurnee, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Columbia University Medical Center

New York, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Texas Digestive Disease Consultants

Cedar Park, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Digestive Health Specialists

Tacoma, Washington, United States

UZ Leuven

Leuven, Belgium

CHC MontLegia

Liège, Belgium

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

ISCARE a.s.

Prague, Czechia

Centrum Medyczne Plejady

Krakow, Poland

Medrise Sp. z o.o.

Lublin, Poland

Eskulap Pabianice Sp. z o.o.

Pabianice, Poland

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

Poznan, Poland

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

Poznan, Poland

Centrum Medyczne Medyk Sp. z o.o.

Rzeszów, Poland

Endoskopia Sp. z o.o.

Sopot, Poland

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

Szczecin, Poland

Gastromed Sp. z o.o.

Torun, Poland

Synexus Polska Sp. z o.o.

Warsaw, Poland

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Poland

PlanetMed Sp. z o.o.

Wroclaw, Poland

EMC Instytut Medyczny S.A. - Wroclaw

Wroclaw, Poland

Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.

Włocławek, Poland

Pro Life Medica Sp. z o.o.

Zamość, Poland

Clinical Hospital Center Zvezdara

Belgrade, Serbia

Military Medical Academy

Belgrade, Serbia

Clinical Center Zemun

Belgrade, Serbia

General Hospital - Djordje Joanovic

Zrenjanin, Serbia

F D Roosevelt University General Hospital Of Banska Bystrica

Banská Bystrica, Slovakia

ENDOMED s.r.o.

Košice, Slovakia

KM Management, spol. s.r.o.

Nitra, Slovakia

Gastro I., s.r.o

Prešov, Slovakia