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

Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
One of a Kind Clinical Research Center
NOT_YET_RECRUITING
Scottsdale
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Connecticut
Medical Research Center of Connecticut, LLC
NOT_YET_RECRUITING
New Haven
Florida
Clinical Research of Osceola
NOT_YET_RECRUITING
Kissimmee
Florida Research Institute
RECRUITING
Lakewood Rch
Medical Professional Clinical Research
NOT_YET_RECRUITING
Miami
Reliant Medical Research
RECRUITING
Miami
University of Miami
RECRUITING
Miami
Illinois
Illinois Gastroenterology Group - Gurnee
RECRUITING
Gurnee
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
North Carolina
Atrium Health
RECRUITING
Charlotte
New York
Columbia University Medical Center
NOT_YET_RECRUITING
New York
Texas
Texas Digestive Disease Consultants
RECRUITING
Cedar Park
Baylor College of Medicine
RECRUITING
Houston
GI Alliance
NOT_YET_RECRUITING
Mansfield
Tyler Research Institute, LLC
NOT_YET_RECRUITING
Tyler
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Digestive Health Specialists
RECRUITING
Tacoma
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
Az Maria Middelares Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
CHC MontLegia
RECRUITING
Liège
Poland
Centrum Medyczne Medis
NOT_YET_RECRUITING
Bydgoszcz
Centrum Medyczne Plejady
RECRUITING
Krakow
Eskulap Pabianice Sp. z o.o.
NOT_YET_RECRUITING
Lodz
Medrise Sp. z o.o.
NOT_YET_RECRUITING
Lublin
Clinical Research Center Sp. z o.o. Medic-R sp.k.
RECRUITING
Poznan
EMC Instytut Medyczny S.A. - Poznan 70-304
RECRUITING
Poznan
Centrum Medyczne Medyk Sp. z o.o.
NOT_YET_RECRUITING
Rzeszów
Endoskopia Sp. z o.o.
RECRUITING
Sopot
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
RECRUITING
Szczecin
Gastromed Sp. z o.o.
NOT_YET_RECRUITING
Torun
NZOZ VIVAMED Jadwiga Miecz
NOT_YET_RECRUITING
Warsaw
Synexus Polska Sp. z o.o.
RECRUITING
Warsaw
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
NOT_YET_RECRUITING
Włocławek
EMC Instytut Medyczny S.A. - Wroclaw 54-144
RECRUITING
Wroclaw
PlanetMed Sp. z o.o.
RECRUITING
Wroclaw
Pro Life Medica Sp. z o.o.
RECRUITING
Zamość
Serbia
Clinical Center Zemun
NOT_YET_RECRUITING
Belgrade
Clinical Hospital Center Dr. Dragisa Misovic
NOT_YET_RECRUITING
Belgrade
Clinical Hospital Center Zvezdara
RECRUITING
Belgrade
Military Medical Academy
NOT_YET_RECRUITING
Belgrade
University Clinical Center of Kragujevac
NOT_YET_RECRUITING
Kragujevac
General Hospital - Djordje Joanovic
RECRUITING
Zrenjanin
Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica
RECRUITING
Banská Bystrica
ENDOMED s.r.o.
NOT_YET_RECRUITING
Košice
KM Management, spol. s.r.o.
RECRUITING
Nitra
Gastro I., s.r.o
RECRUITING
Prešov
Accout Center s.r.o.
NOT_YET_RECRUITING
Šahy
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 40
Treatments
Experimental: All participants
All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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