A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
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
Interventions
BI 3032950 intravenous (Part A)
BI 3032950 subcutaneous (Part B)
Conditions
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