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

NCT06636656 · Boehringer Ingelheim
In plain English

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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
About this study
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 criteria
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.
Study design
Enrollment target: 80 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-11
Estimated completion: 2029-07-30
Last updated: 2026-06-02
Interventions
Drug: BI 3032950 intravenous (Part A)Drug: BI 3032950 subcutaneous (Part B)
Primary outcomes
  • 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, and centrally-read endoscopy subscore [ESS] of 0 or 1 (Up to Week 12)
Sponsor
Boehringer Ingelheim · industry
Contacts & investigators
ContactBoehringer Ingelheim · contact · clintriage.rdg@boehringer-ingelheim.com · 1-800-243-0127
All locations (41)
One of a Kind Clinical Research CenterNot Yet Recruiting
Scottsdale, Arizona, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Clinical Research of OsceolaNot Yet Recruiting
Kissimmee, Florida, United States
Florida Research InstituteRecruiting
Lakewood Rch, Florida, United States
University of MiamiRecruiting
Miami, Florida, United States
Reliant Medical ResearchRecruiting
Miami, Florida, United States
Illinois Gastroenterology Group - GurneeRecruiting
Gurnee, Illinois, United States
University of Kansas Medical CenterNot Yet Recruiting
Kansas City, Kansas, United States
Columbia University Medical CenterNot Yet Recruiting
New York, New York, United States
Atrium Health Gastroenterology and HepatologyRecruiting
Charlotte, North Carolina, United States
Texas Digestive Disease ConsultantsRecruiting
Cedar Park, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
University of WashingtonNot Yet Recruiting
Seattle, Washington, United States
Digestive Health SpecialistsRecruiting
Tacoma, Washington, United States
UZ LeuvenRecruiting
Leuven, Belgium
CHC MontLegiaRecruiting
Liège, Belgium
Hepato-Gastroenterologie HK, s.r.o.Not Yet Recruiting
Hradec Králové, Czechia
ISCARE a.s.Recruiting
Prague, Czechia
Centrum Medyczne PlejadyRecruiting
Krakow, Poland
Medrise Sp. z o.o.Not Yet Recruiting
Lublin, Poland
Eskulap Pabianice Sp. z o.o.Not Yet Recruiting
Pabianice, Poland
EMC Instytut Medyczny S.A. - Poznan 70-304Recruiting
Poznan, Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.Recruiting
Poznan, Poland
Centrum Medyczne Medyk Sp. z o.o.Not Yet Recruiting
Rzeszów, Poland
Endoskopia Sp. z o.o.Recruiting
Sopot, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.Recruiting
Szczecin, Poland
Gastromed Sp. z o.o.Not Yet Recruiting
Torun, Poland
Synexus Polska Sp. z o.o.Recruiting
Warsaw, Poland
NZOZ VIVAMED Jadwiga MieczNot Yet Recruiting
Warsaw, Poland
PlanetMed Sp. z o.o.Recruiting
Wroclaw, Poland
EMC Instytut Medyczny S.A. - WroclawRecruiting
Wroclaw, Poland
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.Not Yet Recruiting
Włocławek, Poland
Pro Life Medica Sp. z o.o.Recruiting
Zamość, Poland
Clinical Hospital Center ZvezdaraRecruiting
Belgrade, Serbia
Military Medical AcademyNot Yet Recruiting
Belgrade, Serbia
Clinical Center ZemunNot Yet Recruiting
Belgrade, Serbia
General Hospital - Djordje JoanovicRecruiting
Zrenjanin, Serbia
F D Roosevelt University General Hospital Of Banska BystricaRecruiting
Banská Bystrica, Slovakia
ENDOMED s.r.o.Recruiting
Košice, Slovakia
KM Management, spol. s.r.o.Recruiting
Nitra, Slovakia
Gastro I., s.r.oRecruiting
Prešov, Slovakia
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis · TrialPath