VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
NCT ID: NCT05370885
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
114 participants
INTERVENTIONAL
2023-05-08
2025-08-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks.
In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
VE202
VE202 is a rationally defined, live biotherapeutic product for oral administration.
Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection
VE202 Placebo
VE202 Placebo
Vancomycin Placebo
Vancomycin Placebo
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks.
In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
VE202
VE202 is a rationally defined, live biotherapeutic product for oral administration.
Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection
VE202 Placebo
VE202 Placebo
Vancomycin Placebo
Vancomycin Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VE202
VE202 is a rationally defined, live biotherapeutic product for oral administration.
Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection
VE202 Placebo
VE202 Placebo
Vancomycin Placebo
Vancomycin Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
3. Active mild to moderate UC, as defined by the following:
1. Disease that extends at least 15 cm from the anal verge
2. A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1
4. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
5. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
6. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
Exclusion Criteria
2. A known diagnosis of primary sclerosing cholangitis
3. Allergy to VE202 or any of its components
4. Allergy to vancomycin or any of its components
5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vedanta Biosciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GI Pros Research
Naples, Florida, United States
Revival Clinical Research
Orlando, Florida, United States
Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
Decatur, Georgia, United States
Boston Medical Center
Boston, Massachusetts, United States
NYU IBD Center
New York, New York, United States
Cornell University Weill Cornell Medicine New York Presbyterian Hospital
New York, New York, United States
Baylor College of Medicine
Houston, Texas, United States
Gastroenterology Research of America, LLC
San Antonio, Texas, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Mater Misericordiae Ltd and Mater Research Ltd
South Brisbane, Queensland, Australia
St Vincent's Hospital Melbourne Department of Gastroenterology
Fitzroy, Victoria, Australia
UMHAT Medica Ruse OOD
Rousse, , Bulgaria
Medical Centre Asklepion Main
Sofia, , Bulgaria
Vojenská nemocnice Brno, Interní oddělení
Brno, , Czechia
PreventaMed s.r.o, Vila zdraví
Olomouc, , Czechia
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, , Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, , Hungary
Dept. Gastroenterology, Univ. Debrecen
Debrecen, , Hungary
Vilnius University Hospital Santaros klinikos
Vilnius, , Lithuania
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
Poznan, Greater Poland Voivodeship, Poland
Medrise Sp. z o.o.
Lublin, Lublin Voivodeship, Poland
MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne "MEDYK"
Rzeszów, Podkarpackie Voivodeship, Poland
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, Poland
Vita Longa Sp. z o.o.
Katowice, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Bonifraterskie Centrum Medyczne Sp. z o.o
Lodz, Łódź Voivodeship, Poland
M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center
Poltava, Poltavska, Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
Regional Clinical Hospital of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, , Ukraine
Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18
Kyiv, , Ukraine
Artes Medikum, Medial Center, Llc
Kyiv, , Ukraine
Medical Center OK!Clinic+
Kyiv, , Ukraine
National Institute of Surgery and Transplantology named after O. O. Shalimova
Kyiv, , Ukraine
LLC Medical Center "Consilium Medical"
Kyiv, , Ukraine
Volyn Regional Clinical hospital
Lutsk, , Ukraine
Ternopil Regional Clinical Hospital
Ternopil, , Ukraine
Uzhgorod City Multidisciplinary Clinical Hospital
Uzhhorod, , Ukraine
Transcarpathian Regional Clinical Hospital named after Andria Novak
Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
Vinnytsia, , Ukraine
Vinnytsia City Clinical Hospital No. 1
Vinnytsia, , Ukraine
UHB NHSFT Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Barts Health NHS TrustThe Royal London Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust - St Mary's Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-001280-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VE202-002
Identifier Type: -
Identifier Source: org_study_id