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A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Sponsor: Boehringer Ingelheim
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
Conditions
Interventions
BI 3032950 intravenous (Part A)
BI 3032950 intravenous (Part A)
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