VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
- Conditions
- Ulcerative ColitisColitis, Ulcerative
- Interventions
- Registration Number
- NCT05370885
- Lead Sponsor
- Vedanta Biosciences, Inc.
- Brief Summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
- Detailed Description
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. Vancomycin Oral Capsule 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. Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. VE202 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. Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. VE202 Placebo 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. Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. Vancomycin Placebo 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. Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. VE202 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. Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. VE202 Placebo 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. Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. Vancomycin Oral Capsule 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. Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. Vancomycin Placebo 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.
- Primary Outcome Measures
Name Time Method Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo. 8 Weeks Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study. 16 Weeks The safety of VE202 and placebo in Parts 1 and 2 of the study, which include an 8-week and 2-week course of treatment, respectively, will be evaluated.
- Secondary Outcome Measures
Name Time Method Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2. 8 Weeks Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical remission is defined as attaining a Mayo stool frequency subscore of ≤1 and an improvement in stool frequency subscore of ≥1 point from baseline, a rectal bleeding subscore of 0 and an endoscopic subscore ≤1. Each component of the Mayo score is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2. 8 Weeks Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Endoscopic response is defined as a Mayo endoscopic subscore of 0 or 1 point. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2. 8 Weeks Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician global assessment), with each parameter evaluated on a scale of 0 to 3. The total score ranges from 0 to 12, and a higher score represents more severe disease.
Change in the total percent of relative abundance of VE202 strains in feces at various time points in patients treated with 2- and 8-week courses of VE202. 52 Weeks VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life. 52 Weeks The 32-item IBDQ uses a 7-point scale to assess disease-specific health-related quality of life across 4 dimensions: bowel symptoms, systemic symptoms, emotional wellbeing, and social function. The total IBDQ score is calculated by adding the scores within each domain. Scores can range from 32 to 224, with a higher score indicating a better outcome.
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score. 8 Weeks Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Geboes score encompasses 6 dimensions, each with 4 subcategories: architectural changes, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium, crypt destruction, and erosions or ulcerations. The Geboes score ranges from grade 0 to 5.4. A higher Geboes score represents more severe disease.
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study. 52 Weeks The safety of VE202 and placebo in Parts 1, 2, and 3 of the study, which include an 8-week and 2-week course of treatment followed by a long-term follow-up period, will be evaluated. AESIs are defined as treatment-related Grade ≥2 TEAEs that are gastrointestinal or bacterial infections.
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202. 52 Weeks VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Change in patient-reported outcome measures using the EuroQoL-5D Health Assessment Questionnaire (EQ-5D) scores to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life. 52 Weeks The EuroQoL-5D Health Assessment Questionnaire (EQ-5D) is a standardized, self-administered, non-disease-specific instrument for measuring generic health status for routine clinical outcome measurement in the delivery of operational healthcare. Scores range from 0 to 100, with a higher score indicating better outcome.
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks. 8 Weeks Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2. 8 Weeks Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical response is defined as having met the definition of clinical remission or having a decrease from baseline of ≥2 points and a decrease of ≥30% in modified Mayo score, with either a rectal bleeding score of 0 or a decrease in rectal bleeding of ≥1 point. Each component of the modified Mayo score (stool frequency, rectal bleeding, endoscopy findings) is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Change in fecal calprotectin levels after 2- and 8-week courses of VE202. 52 Weeks The change in fecal calprotectin level from baseline will be evaluated.
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202. 52 Weeks Microbiome composition will be evaluated by measuring the sum of species and the genera or higher-level taxonomic groupings at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points. 52 Weeks Short-chain fatty acid and bile acid concentrations will be evaluated at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI). 8 Weeks Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The RHI provides a score between 0 and 33, based on the levels of chronic inflammatory infiltrate, neutrophils in lamina propria and epithelium, and erosion/ulceration. A higher RHI score represents more severe disease.
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202. 52 weeks To evaluate the impact of 2- and 8-week courses of VE202 on Inflammatory bowel disease (IBD) specific healthcare resource utilization.
Trial Locations
- Locations (68)
Clinical Applications Laboratories
🇺🇸San Diego, California, United States
Digestive Health Specialists
🇺🇸Dothan, Alabama, United States
GastroIntestinal BioSciences
🇺🇸Los Angeles, California, United States
University of Miami
🇺🇸Miami, Florida, United States
GI Pros Research
🇺🇸Naples, Florida, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
Revival Clinical Research
🇺🇸Orlando, Florida, United States
Omega Research Orlando, LLC
🇺🇸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
Mayo Clinic
🇺🇸Rochester, Minnesota, 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
Manhattan Clinical Research, LLC
🇺🇸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
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
South Western Sydney Local Health District
🇦🇺Liverpool, 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
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
UMHAT Medica Ruse OOD
🇧🇬Ruse, Bulgaria
Medical Centre Asklepion Main
🇧🇬Sofia, Bulgaria
Medical Centre Leo Clinic EOOD
🇧🇬Varna, Bulgaria
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Králové, Czech Republic
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
Klaipeda University Hospital
🇱🇹Klaipėda, Lithuania
Vilnius University Hospital Santaros klinikos
🇱🇹Vilnius, Lithuania
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Gelderland, Netherlands
Zuyderland Medical Center
🇳🇱Sittard, Limburg, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Vistamed & Vertigo Sp. z o.o.
🇵🇱Wroclaw, Dolnośląskie, Poland
Medrise Sp. z o.o.
🇵🇱Lublin, Lubelskie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Kliniczny Oddział Gastroenterologii z Pracownią Endoskopową
🇵🇱Lublin, Lubelskie, Poland
Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) VIVAMED Jadwiga Miecz
🇵🇱Warszawa, Mazowieckie, Poland
MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point
🇵🇱Warszawa, Mazowieckie, Poland
Krakowskie Centrum Medyczne
🇵🇱Kraków, Małopolskie, Poland
Centrum Medyczne "MEDYK"
🇵🇱Rzeszów, Podkarpackie, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Pomorskie, Poland
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
🇵🇱Poznan, Wielkopolskie, Poland
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Solumed Centrum Medyczne
🇵🇱Poznań, Poland
Bonifraterskie Centrum Medyczne Sp. z o.o
🇵🇱Łódź, Łódzkie, 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-Frankivs'k, 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
🇺🇦Luts'k, Ukraine
Ternopil Regional Clinical Hospital
🇺🇦Ternopil', Ukraine
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
🇺🇦Vinnytsia, Ukraine
Vinnytsia City Clinical Hospital No. 1
🇺🇦Vinnytsia, Ukraine
Uzhgorod City Multidisciplinary Clinical Hospital
🇺🇦Úzhgorod, Ukraine
Transcarpathian Regional Clinical Hospital named after Andria Novak
🇺🇦Úzhgorod, 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