UCRecruiting
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Phase 2 · Testing BI 3032950 intravenous (Part A) and BI 3032950 subcutaneous (Part B) · 41 sites · Boehringer Ingelheim
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing BI 3032950 intravenous (Part A) (a drug) and BI 3032950 subcutaneous (Part B) (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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,
Plus 2 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2024-12-11.
- Main results expected around 2027-07-30 (estimate from the record).
- 41 study sites listed (34 marked recruiting) in Belgium, Czechia, Poland, Serbia and Slovakia and 1 more countries.
Main thing being measured
- Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0,… (Up to Week 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Boehringer Ingelheim |
| Enrollment | 80 (estimated) |
| Start date | 2024-12-11 |
| Primary completion (est.) | 2027-07-30 |
| First posted | 2024-10-15 |
| Last updated | 2026-08-21 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06636656 |
Interventions
- BI 3032950 intravenous (Part A) (Drug)
BI 3032950 intravenous (Part A) - BI 3032950 subcutaneous (Part B) (Drug)
BI 3032950 subcutaneous (Part B)
Full eligibility criteria (from the record)
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.
Locations (41)
Show all 41 sites
| Site | City | Country | Site status |
|---|---|---|---|
| One of a Kind Clinical Research Center | Scottsdale, Arizona | United States | Not yet recruiting |
| Peak Gastroenterology Associates | Colorado Springs, Colorado | United States | Recruiting |
| Primary Care of Osceola | Kissimmee, Florida | United States | Not yet recruiting |
| Florida Research Institute | Lakewood Rch, Florida | United States | Recruiting |
| University of Miami | Miami, Florida | United States | Recruiting |
| Reliant Medical Research | Miami, Florida | United States | Recruiting |
| Illinois Gastroenterology Group - Gurnee | Gurnee, Illinois | United States | Recruiting |
| University of Kansas Medical Center | Kansas City, Kansas | United States | Recruiting |
| Columbia University Medical Center | New York, New York | United States | Not yet recruiting |
| Atrium Health Gastroenterology and Hepatology | Charlotte, North Carolina | United States | Recruiting |
| Texas Digestive Disease Consultants | Cedar Park, Texas | United States | Recruiting |
| Baylor College of Medicine | Houston, Texas | United States | Recruiting |
| University of Washington | Seattle, Washington | United States | Not yet recruiting |
| Digestive Health Specialists | Tacoma, Washington | United States | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| CHC MontLegia | Liège | Belgium | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | Not yet recruiting |
| ISCARE a.s. | Prague | Czechia | Recruiting |
| Centrum Medyczne Plejady | Krakow | Poland | Recruiting |
| Medrise Sp. z o.o. | Lublin | Poland | Recruiting |
| Eskulap Pabianice Sp. z o.o. | Pabianice | Poland | Recruiting |
| EMC Instytut Medyczny S.A. - Poznan 70-304 | Poznan | Poland | Recruiting |
| Clinical Research Center Sp. z o.o. Medic-R sp.k. | Poznan | Poland | Recruiting |
| Centrum Medyczne Medyk Sp. z o.o. | Rzeszów | Poland | Recruiting |
| Endoskopia Sp. z o.o. | Sopot | Poland | Recruiting |
| Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. | Szczecin | Poland | Recruiting |
| Gastromed Sp. z o.o. | Torun | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Warsaw | Poland | Recruiting |
| NZOZ VIVAMED Jadwiga Miecz | Warsaw | Poland | Recruiting |
| PlanetMed Sp. z o.o. | Wroclaw | Poland | Recruiting |
| EMC Instytut Medyczny S.A. - Wroclaw | Wroclaw | Poland | Recruiting |
| Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. | Włocławek | Poland | Recruiting |
| Pro Life Medica Sp. z o.o. | Zamość | Poland | Recruiting |
| Clinical Hospital Center Zvezdara | Belgrade | Serbia | Recruiting |
| Military Medical Academy | Belgrade | Serbia | Not yet recruiting |
| Clinical Center Zemun | Belgrade | Serbia | Not yet recruiting |
| General Hospital - Djordje Joanovic | Zrenjanin | Serbia | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica | Banská Bystrica | Slovakia | Recruiting |
| ENDOMED s.r.o. | Košice | Slovakia | Recruiting |
| KM Management, spol. s.r.o. | Nitra | Slovakia | Recruiting |
| Gastro I., s.r.o | Prešov | Slovakia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.