Phase
Condition
Crohn's Disease
Ulcers
Ulcerative Colitis
Treatment
VE202 Placebo
Vancomycin Oral Capsule
Vancomycin Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
KEY INCLUSION CRITERIA
18 to 75 years of age
Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
Active mild to moderate UC, as defined by the following:
Disease that extends at least 15 cm from the anal verge
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
Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
KEY EXCLUSION CRITERIA
Known history of Crohn's disease (CD) or indeterminate colitis
A known diagnosis of primary sclerosing cholangitis
Allergy to VE202 or any of its components
Allergy to vancomycin or any of its components
A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
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)
Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
Study Design
Study Description
Connect with a study center
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaSite Not Available
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
South Western Sydney Local Health District
Liverpool, New South Wales 1871
AustraliaSite Not Available
Mater Misericordiae Ltd and Mater Research Ltd
South Brisbane, Queensland 4101
AustraliaSite Not Available
St Vincent's Hospital Melbourne Department of Gastroenterology
Fitzroy, Victoria 3065
AustraliaSite Not Available
Medical Center Medconsult Pleven OOD
Pleven, 5800
BulgariaSite Not Available
UMHAT Medica Ruse OOD
Ruse, 7013
BulgariaSite Not Available
Medical Centre Asklepion Main
Sofia, 1303
BulgariaSite Not Available
Medical Centre Leo Clinic EOOD
Varna, 9020
BulgariaSite Not Available
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
Czech RepublicSite Not Available
Vojenská nemocnice Brno, Interní oddělení
Brno, 61500
CzechiaSite Not Available
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012
CzechiaActive - Recruiting
PreventaMed s.r.o, Vila zdraví
Olomouc, 77900
CzechiaSite Not Available
Pannónia Magánorvosi Centrum Kft
Budapest, 1136
HungarySite Not Available
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, 1088
HungarySite Not Available
Dept. Gastroenterology, Univ. Debrecen
Debrecen, H-4032
HungarySite Not Available
Klaipeda University Hospital
Klaipėda, LT-92288
LithuaniaSite Not Available
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08661
LithuaniaSite Not Available
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland 6525 GA
NetherlandsSite Not Available
Zuyderland Medical Center
Sittard, Limburg 6162BG
NetherlandsSite Not Available
Leiden University Medical Center
Leiden, 2333 ZA
NetherlandsSite Not Available
Vistamed & Vertigo Sp. z o.o.
Wroclaw, Dolnośląskie 53-149
PolandSite Not Available
Vistamed & Vertigo Sp. z o.o.
Wrocław, Dolnośląskie 53-149
PolandSite Not Available
Medrise Sp. z o.o.
Lublin, Lubelskie 20-582
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Kliniczny Oddział Gastroenterologii z Pracownią Endoskopową
Lublin, Lubelskie 20-954
PolandSite Not Available
MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point
Warszawa, Mazowieckie 04-501
PolandSite Not Available
Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) VIVAMED Jadwiga Miecz
Warszawa, Mazowieckie 03-580
PolandSite Not Available
Institution name: Krakowskie Centrum Medyczne
Kraków, Małopolskie 31-501
PolandActive - Recruiting
Krakowskie Centrum Medyczne
Kraków, Małopolskie 31-501
PolandSite Not Available
Centrum Medyczne "MEDYK"
Rzeszów, Podkarpackie 35-326
PolandSite Not Available
Endoskopia Sp. z o.o.
Sopot, Pomorskie 81-756
PolandSite Not Available
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
Poznan, Wielkopolskie 61-731
PolandSite Not Available
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
Poznań, Wielkopolskie 61-731
PolandActive - Recruiting
Bonifraterskie Centrum Medyczne Sp. z o.o
Łódź, Łódzkie 93-357
PolandSite Not Available
Vita Longa Sp. z o.o.
Katowice, 40748
PolandSite Not Available
Solumed Centrum Medyczne
Poznań, 60-529
PolandSite Not Available
M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center
Poltava, Poltavska 36011
UkraineSite Not Available
Chernivtsi Regional Clinical Hospital
Chernivtsi, 03110
UkraineSite Not Available
Regional Clinical Hospital of the Ivano-Frankivsk Regional Council
Ivano-Frankivs'k, 76000
UkraineSite Not Available
Artes Medikum, Medial Center, Llc
Kyiv, 02002
UkraineSite Not Available
LLC Medical Center "Consilium Medical"
Kyiv, 04050
UkraineSite Not Available
Medical Center Medical Clinic Blagomed LLC
Kyiv, 1023
UkraineActive - Recruiting
Medical Center OK!Clinic+
Kyiv, 02091
UkraineSite Not Available
Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18
Kyiv, 01054
UkraineSite Not Available
National Institute of Surgery and Transplantology named after O. O. Shalimova
Kyiv, 03126
UkraineSite Not Available
Volyn Regional Clinical hospital
Luts'k, 43000
UkraineSite Not Available
Ternopil Regional Clinical Hospital
Ternopil', 46002
UkraineSite Not Available
Vinnytsia City Clinical Hospital No. 1
Vinnytsia, 21029
UkraineSite Not Available
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
Vinnytsia, 21000
UkraineSite Not Available
Transcarpathian Regional Clinical Hospital named after Andria Novak
Úzhgorod, 88018
UkraineSite Not Available
Uzhgorod City Multidisciplinary Clinical Hospital
Úzhgorod, 88009
UkraineSite Not Available
UHB NHSFT Queen Elizabeth Hospital
Birmingham, West Midlands B15 2TH
United KingdomSite Not Available
Barts Health NHS TrustThe Royal London Hospital
London, E1 2AJ
United KingdomSite Not Available
Imperial College Healthcare NHS Trust - St Mary's Hospital
London, W2 1NY
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
Dawn Barnes
Dothan, Alabama 36305-1156
United StatesSite Not Available
Digestive Health Specialists
Dothan, Alabama 36305-1156
United StatesSite Not Available
GastroIntestinal BioSciences
Los Angeles, California 90067
United StatesSite Not Available
Clinical Applications Laboratories
San Diego, California 92103
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
GI Pros Research
Naples, Florida 34102
United StatesSite Not Available
GO Pros
Naples, Florida 34102
United StatesActive - Recruiting
Advanced Research Institute, Inc.
New Port Richey, Florida 34653
United StatesSite Not Available
Christina Velazquez
New Port Richey, Florida 34653
United StatesActive - Recruiting
Danielle Cortese
Orlando, Florida 32808
United StatesActive - Recruiting
Omega Research Orlando, LLC
Orlando, Florida 32808
United StatesSite Not Available
Revival Clinical Research
Orlando, Florida 32807
United StatesSite Not Available
Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
Decatur, Georgia 30033-6146
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Cornell University Weill Cornell Medicine New York Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
Glenda Alfonso Castillo
New York, New York 10279
United StatesActive - Recruiting
Manhattan Clinical Research, LLC
New York, New York 10279
United StatesSite Not Available
NYU IBD Center
New York, New York 10016
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Gastroenterology Research of America, LLC
San Antonio, Texas 78229
United StatesSite Not Available
University of Utah Hospitals and Clinics
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
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