VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis; Colitis, Ulcerative
• Intervention / Treatment: Biological: VE202; Drug: Vancomycin Oral Capsule; Other: VE202 Placebo; Other: Vancomycin Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Ltd and Mater Research Ltd
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne Department of Gastroenterology
• Bulgaria
  • Rousse, Bulgaria, 7013
    • UMHAT Medica Ruse OOD
  • Sofia, Bulgaria, 1303
    • Medical Centre Asklepion Main
• Czechia
  • Brno, Czechia, 61500
    • Vojenska nemocnice Brno, Interni oddeleni
  • Olomouc, Czechia, 77900
    • PreventaMed s.r.o, Vila zdraví
• Hungary
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum Kft
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
  • Debrecen, Hungary, H-4032
    • Dept. Gastroenterology, Univ. Debrecen
• Lithuania
  • Vilnius, Lithuania, LT-08661
    • Vilnius University hospital Santaros klinikos
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Leiden University Medical Center
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum
• Poland
  • Katowice, Poland, 40748
    • Vita Longa Sp. z o.o.
  • Poznan, Poland, 60-529
    • Solumed Centrum Medyczne
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-731
      • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-582
      • Medrise Sp. z o.o.
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 04-501
      • MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-326
      • Centrum Medyczne "MEDYK"
  • Pomeranian Voivodeship
    • Sopot, Pomeranian Voivodeship, Poland, 81-756
      • Endoskopia Sp. z o.o.
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 93-357
      • Bonifraterskie Centrum Medyczne sp. z o.o
• Ukraine
  • Chernivtsi, Ukraine, 03110
    • Chernivtsi Regional Clinical Hospital
  • Ivano-Frankivsk, Ukraine, 76000
    • Regional Clinical Hospital of the Ivano-Frankivsk Regional Council
  • Kyiv, Ukraine, 02091
    • Medical Center Ok!Clinic+
  • Kyiv, Ukraine, 01054
    • Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18
  • Kyiv, Ukraine, 02002
    • Artes Medikum, Medial Center, Llc
  • Kyiv, Ukraine, 03126
    • National Institute of Surgery and Transplantology named after O. O. Shalimova
  • Kyiv, Ukraine, 04050
    • LLC Medical Center "Consilium Medical"
  • Lutsk, Ukraine, 43000
    • Volyn Regional Clinical Hospital
  • Ternopil, Ukraine, 46002
    • Ternopil Regional Clinical Hospital
  • Uzhhorod, Ukraine, 88009
    • Uzhgorod City Multidisciplinary Clinical Hospital
  • Uzhhorod, Ukraine, 88018
    • Transcarpathian Regional Clinical Hospital named after Andria Novak
  • Vinnytsia, Ukraine, 21000
    • Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
  • Vinnytsia, Ukraine, 21029
    • Vinnytsia City Clinical Hospital No. 1
  • Poltavska
    • Poltava, Poltavska, Ukraine, 36011
      • M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust - St Mary's Hospital
  • London, United Kingdom, E1 2AJ
    • Barts Health NHS TrustThe Royal London Hospital
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • UHB NHSFT Queen Elizabeth Hospital
• United States
  • Florida
    • Naples, Florida, United States, 34102
      • GI Pros Research
    • Orlando, Florida, United States, 32807
      • Revival Clinical Research
  • Georgia
    • Decatur, Georgia, United States, 30033-6146
      • Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU IBD Center
    • New York, New York, United States, 10021
      • Cornell University Weill Cornell Medicine New York Presbyterian Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of America, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospitals and Clinics
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

KEY INCLUSION CRITERIA

1. 18 to 75 years of age
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

KEY EXCLUSION CRITERIA

1. Known history of Crohn's disease (CD) or indeterminate colitis
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Biological: VE202; VE202 is a rationally defined, live biotherapeutic product for oral administration.; Drug: Vancomycin Oral Capsule; Vancomycin is an antibiotic used to treat or prevent infection; Other: VE202 Placebo; VE202 Placebo; Other: Vancomycin Placebo; Vancomycin Placebo
Other: 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.	Biological: VE202; VE202 is a rationally defined, live biotherapeutic product for oral administration.; Drug: Vancomycin Oral Capsule; Vancomycin is an antibiotic used to treat or prevent infection; Other: VE202 Placebo; VE202 Placebo; Other: Vancomycin Placebo; Vancomycin Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.	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.	8 Weeks
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.	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.	16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 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.	8 Weeks
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.	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.	52 Weeks
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.	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.	8 Weeks
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.	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.	8 Weeks
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.	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.	8 Weeks
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.	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.	8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.	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.	8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).	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.	8 Weeks
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.	The change in fecal calprotectin level from baseline will be evaluated.	52 Weeks
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.	VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.	52 Weeks
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.	VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.	52 Weeks
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.	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.	52 Weeks
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.	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.	52 Weeks
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.	To evaluate the impact of 2- and 8-week courses of VE202 on Inflammatory bowel disease (IBD) specific healthcare resource utilization.	52 weeks
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.	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.	52 Weeks
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.	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.	52 Weeks

Collaborators and Investigators

• Sponsor: Vedanta Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Vedanta; VE202; Clostridia
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Peptides; Amino Acids, Peptides, and Proteins; Carbohydrates; Glycoconjugates; Glycopeptides; Vancomycin
• Other Study ID Numbers: VE202-002; 2021-001280-24 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes