ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-12-11
Study Completion:2028-02-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06636656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

One of a Kind Clinical Research Center
Scottsdale, Arizona, 85258
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States
Medical Research Center of Connecticut, LLC
New Haven, Connecticut, 06518-3691
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
Medical Professional Clinical Research
Miami, Florida, 33165
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
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
GI Alliance
Mansfield, Texas, 76063
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
University of Washington
Seattle, Washington, 98195-0001
United States
Digestive Health Specialists
Tacoma, Washington, 98405-2318
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2028-02-29

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2028-02-29

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis