A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Recruiting · NCT06636656 · Interventional (participants receive a specific treatment) · Lead sponsor: Boehringer Ingelheim
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
- Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
- Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
- Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
- Evidence of fulminant colitis or toxic megacolon at screening,
- Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
- Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
- Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
- Further exclusion criteria apply.
Where it is running
41 locations listed across 9 US states.
- One of a Kind Clinical Research Center - Scottsdale, Arizona, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Primary Care 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 Gastroenterology and Hepatology - 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
- F D Roosevelt University General Hospital Of Banska Bystrica - Banská Bystrica, Slovakia
- Clinical Hospital Center Zvezdara - Belgrade, Serbia
- Military Medical Academy - Belgrade, Serbia
- Clinical Center Zemun - Belgrade, Serbia
- Hepato-Gastroenterologie HK, s.r.o. - Hradec Králové, Czechia
- ENDOMED s.r.o. - Košice, Slovakia
- Centrum Medyczne Plejady - Krakow, Poland
- UZ Leuven - Leuven, Belgium
- CHC MontLegia - Liège, Belgium
- Medrise Sp. z o.o. - Lublin, Poland
- KM Management, spol. s.r.o. - Nitra, Slovakia
- 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
- ISCARE a.s. - Prague, Czechia
- Gastro I., s.r.o - Prešov, Slovakia
- 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
- General Hospital - Djordje Joanovic - Zrenjanin, Serbia