VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

March 29, 2024 updated by: Vedanta Biosciences, Inc.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical Center Medconsult Pleven OOD
        • Contact:
      • Ruse, Bulgaria, 7013
        • Recruiting
        • UMHAT Medica Ruse OOD
        • Contact:
          • Fatme Minkova
          • Phone Number: +359 884 460 103
          • Email: zkm4@abv.bg
      • Sofia, Bulgaria, 1303
        • Recruiting
        • Medical Centre Asklepion Main
        • Contact:
      • Varna, Bulgaria, 9020
        • Active, not recruiting
        • Medical Centre Leo Clinic EOOD
  • Czechia
      • Brno, Czechia, 61500
        • Recruiting
        • Vojenská nemocnice Brno, Interní oddělení
        • Contact:
      • Hradec Králové, Czechia, 50012
      • Olomouc, Czechia, 77900
        • Recruiting
        • PreventaMed s.r.o, Vila zdraví
        • Contact:
  • Hungary
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1136
        • Recruiting
        • Pannónia Magánorvosi Centrum Kft
        • Contact:
      • Debrecen, Hungary, H-4032
        • Recruiting
        • Dept. Gastroenterology, Univ. Debrecen
        • Contact:
  • Lithuania
      • Klaipėda, Lithuania, LT-92288
        • Recruiting
        • Klaipeda University Hospital
        • Contact:
      • Vilnius, Lithuania, LT-08661
        • Recruiting
        • Vilnius University hospital Santaros klinikos
        • Contact:
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
    • Limburg
      • Sittard, Limburg, Netherlands, 6162BG
        • Recruiting
        • Zuyderland Medical Center
        • Contact:
  • Poland
    • Dolnośląskie
      • Wrocław, Dolnośląskie, Poland, 53-149
        • Recruiting
        • Vistamed & Vertigo Sp. z o.o.
        • Contact:
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 03-580
        • Recruiting
        • Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) VIVAMED Jadwiga Miecz
        • Contact:
    • Małopolskie
      • Kraków, Małopolskie, Poland, 31-501
        • Recruiting
        • Institution name: Krakowskie Centrum Medyczne
        • Contact:
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 61-731
        • Recruiting
        • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
        • Contact:
    • Łódzkie
      • Łódź, Łódzkie, Poland, 93-357
        • Recruiting
        • Bonifraterskie Centrum Medyczne Sp. z o.o
        • Contact:
  • Ukraine
      • Chernivtsi, Ukraine, 03110
        • Recruiting
        • Chernivtsi Regional Clinical Hospital
        • Contact:
      • Ivano-Frankivs'k, Ukraine, 76000
        • Recruiting
        • Regional Clinical Hospital of the Ivano-Frankivsk Regional Council
        • Contact:
      • Kyiv, Ukraine, 02091
      • Kyiv, Ukraine, 03126
        • Recruiting
        • National Institute of Surgery and Transplantology named after O. O. Shalimova
        • Contact:
      • Kyiv, Ukraine, 1023
        • Recruiting
        • Medical Center Medical Clinic Blagomed LLC
        • Contact:
      • Kyiv, Ukraine, 04050
        • Recruiting
        • LLC Medical Center "Consilium Medical"
        • Contact:
      • Luts'k, Ukraine, 43000
        • Recruiting
        • Volyn Regional Clinical Hospital
        • Contact:
      • Ternopil', Ukraine, 46002
        • Recruiting
        • Ternopil Regional Clinical Hospital
        • Contact:
      • Vinnytsia, Ukraine, 21000
        • Recruiting
        • Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
        • Contact:
      • Vinnytsia, Ukraine, 21029
        • Recruiting
        • Vinnytsia City Clinical Hospital No. 1
        • Contact:
      • Úzhgorod, Ukraine, 88009
        • Recruiting
        • Uzhgorod City Multidisciplinary Clinical Hospital
        • Contact:
      • Úzhgorod, Ukraine, 88018
        • Recruiting
        • Transcarpathian Regional Clinical Hospital named after Andria Novak
        • Contact:
  • United Kingdom
      • London, United Kingdom, E1 2AJ
        • Recruiting
        • Barts Health NHS TrustThe Royal London Hospital
        • Contact:
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305-1156
        • Recruiting
        • Digestive Health Specialists
        • Contact:
    • California
      • Los Angeles, California, United States, 90067
        • Recruiting
        • GastroIntestinal BioSciences
        • Contact:
      • San Diego, California, United States, 92103
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
      • Naples, Florida, United States, 34102
      • New Port Richey, Florida, United States, 34653
      • Orlando, Florida, United States, 32808
        • Recruiting
        • Omega Research Orlando, LLC
        • Contact:
      • Orlando, Florida, United States, 32807
    • Georgia
      • Decatur, Georgia, United States, 30033-6146
        • Recruiting
        • Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10279
        • Recruiting
        • Manhattan Clinical Research, LLC
        • Contact:
      • New York, New York, United States, 10016
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Gastroenterology Research of America, LLC
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Hospitals and Clinics
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
8 Weeks
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
Time Frame: 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.
52 Weeks
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
Time Frame: 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.
8 Weeks
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
Time Frame: 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.
8 Weeks
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
Time Frame: 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.
8 Weeks
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
Time Frame: 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.
8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
Time Frame: 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.
8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
Time Frame: 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.
8 Weeks
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
Time Frame: 52 Weeks
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.
Time Frame: 52 Weeks
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.
Time Frame: 52 Weeks
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.
Time Frame: 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.
52 Weeks
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
Time Frame: 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.
52 Weeks
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
Time Frame: 52 weeks
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.
Time Frame: 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.
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.
Time Frame: 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.
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vedanta Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

November 10, 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 (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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