NCT06636656RecruitingPhase 2
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Phase IIa, Sequential Cohort, 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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- 11 Dec 2024
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Ulcerative colitis
- NCT number
- NCT06636656
- EU CT number
- 2023-509544-10-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 11 Dec 2024 to the primary completion date, 30 Jul 2027
- 41 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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,
Other illness
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
Other
- 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,
- Further exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Not yet recruiting |
| ISCARE a.s. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Centrum Medyczne Plejady Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Eskulap Pabianice Sp. z o.o. Coordinator of this site? Confirm its status | Pabianice | Poland | Recruiting |
| EMC Instytut Medyczny S.A. - Poznan 70-304 Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Recruiting |
| Endoskopia Sp z o.o. Coordinator of this site? Confirm its status | Sopot | Poland | Recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| GASTROMED Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Synexus Polska Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| NZOZ VIVAMED Jadwiga Miecz Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Coordinator of this site? Confirm its status | Włocławek | Poland | Recruiting |
| PlanetMed Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| EMC Instytut Medyczny S.A. - Wroclaw Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Pro Life Medica Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Recruiting |
| Clinical. Hospital Center Zvezdara Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Clinical Center Zemun Coordinator of this site? Confirm its status | Belgrade | Serbia | Not yet recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Belgrade | Serbia | Not yet recruiting |
| General Hospital - Djordje Joanovic Coordinator of this site? Confirm its status | Zrenjanin | Serbia | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica Coordinator of this site? Confirm its status | Banska Bystrica | Slovakia | Recruiting |
| ENDOMED, s.r.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| KM Management spol. s r.o. Coordinator of this site? Confirm its status | Nitra | Slovakia | Recruiting |
| GASTRO I., s.r.o. Coordinator of this site? Confirm its status | Prešov | Slovakia | Recruiting |
| Texas Digestive Disease Consultants Coordinator of this site? Confirm its status | Cedar Park | United States | Recruiting |
| Atrium Health Gastroenterology and Hepatology Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Peak Gastroenterology Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Illinois Gastroenterology Group - Gurnee Coordinator of this site? Confirm its status | Gurnee | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Primary Care of Osceola Coordinator of this site? Confirm its status | Kissimmee | United States | Not yet recruiting |
| Florida Research Institute Coordinator of this site? Confirm its status | Lakewood Rch | United States | Recruiting |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Reliant Medical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| One of a Kind Clinical Research Center Coordinator of this site? Confirm its status | Scottsdale | United States | Not yet recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| Digestive Health Specialists Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.