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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05370885




Registration number
NCT05370885
Ethics application status
Date submitted
30/03/2022
Date registered
12/05/2022
Date last updated
1/07/2024

Titles & IDs
Public title
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Scientific title
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Secondary ID [1] 0 0
2021-001280-24
Secondary ID [2] 0 0
VE202-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - VE202
Treatment: Drugs - Vancomycin Oral Capsule
Other interventions - VE202 Placebo
Other interventions - Vancomycin Placebo

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.

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.


Treatment: Other: VE202
VE202 is a rationally defined, live biotherapeutic product for oral administration.

Treatment: Drugs: Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection

Other interventions: VE202 Placebo
VE202 Placebo

Other interventions: Vancomycin Placebo
Vancomycin Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
Timepoint [1] 0 0
8 Weeks
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
16 Weeks
Secondary outcome [1] 0 0
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
Timepoint [1] 0 0
8 Weeks
Secondary outcome [2] 0 0
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
Timepoint [3] 0 0
8 Weeks
Secondary outcome [4] 0 0
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
Timepoint [4] 0 0
8 Weeks
Secondary outcome [5] 0 0
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
Timepoint [5] 0 0
8 Weeks
Secondary outcome [6] 0 0
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
Timepoint [6] 0 0
8 Weeks
Secondary outcome [7] 0 0
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
Timepoint [7] 0 0
8 Weeks
Secondary outcome [8] 0 0
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
Timepoint [8] 0 0
8 Weeks
Secondary outcome [9] 0 0
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
Timepoint [9] 0 0
52 Weeks
Secondary outcome [10] 0 0
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
Timepoint [10] 0 0
52 Weeks
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
52 Weeks
Secondary outcome [12] 0 0
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
Timepoint [12] 0 0
52 Weeks
Secondary outcome [13] 0 0
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
Timepoint [13] 0 0
52 Weeks
Secondary outcome [14] 0 0
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
Timepoint [14] 0 0
52 weeks
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
52 Weeks
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
52 Weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/11/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Misericordiae Ltd and Mater Research Ltd - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Pleven
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Ruse
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Varna
Country [15] 0 0
Czechia
State/province [15] 0 0
Brno
Country [16] 0 0
Czechia
State/province [16] 0 0
Hradec Králové
Country [17] 0 0
Czechia
State/province [17] 0 0
Olomouc
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Hungary
State/province [19] 0 0
Debrecen
Country [20] 0 0
Lithuania
State/province [20] 0 0
Klaipeda
Country [21] 0 0
Lithuania
State/province [21] 0 0
Vilnius
Country [22] 0 0
Netherlands
State/province [22] 0 0
Gelderland
Country [23] 0 0
Netherlands
State/province [23] 0 0
Limburg
Country [24] 0 0
Netherlands
State/province [24] 0 0
Leiden
Country [25] 0 0
Poland
State/province [25] 0 0
Dolnoslaskie
Country [26] 0 0
Poland
State/province [26] 0 0
Lubelskie
Country [27] 0 0
Poland
State/province [27] 0 0
Mazowieckie
Country [28] 0 0
Poland
State/province [28] 0 0
Malopolskie
Country [29] 0 0
Poland
State/province [29] 0 0
Pomorskie
Country [30] 0 0
Poland
State/province [30] 0 0
Wielkopolskie
Country [31] 0 0
Poland
State/province [31] 0 0
Katowice
Country [32] 0 0
Poland
State/province [32] 0 0
Poznan
Country [33] 0 0
Poland
State/province [33] 0 0
Lódzkie
Country [34] 0 0
Ukraine
State/province [34] 0 0
Chernivtsi
Country [35] 0 0
Ukraine
State/province [35] 0 0
Ivano-Frankivs'k
Country [36] 0 0
Ukraine
State/province [36] 0 0
Kyiv
Country [37] 0 0
Ukraine
State/province [37] 0 0
Luts'k
Country [38] 0 0
Ukraine
State/province [38] 0 0
Ternopil'
Country [39] 0 0
Ukraine
State/province [39] 0 0
Vinnytsia
Country [40] 0 0
Ukraine
State/province [40] 0 0
Úzhgorod
Country [41] 0 0
United Kingdom
State/province [41] 0 0
West Midlands
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vedanta Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mary Garfield, MS
Address 0 0
Country 0 0
Phone 0 0
203.906.5693
Fax 0 0
Email 0 0
Consortium02-ctinquiries@vedantabio.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05370885