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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
24/06/2025
Titles & IDs
Public title
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
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Scientific title
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
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Secondary ID [1]
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2021-001280-24
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Secondary ID [2]
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VE202-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
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Assessment method [1]
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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.
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Timepoint [1]
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8 Weeks
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Primary outcome [2]
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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.
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Assessment method [2]
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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.
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Timepoint [2]
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16 Weeks
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Secondary outcome [1]
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Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
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Assessment method [1]
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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.
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Timepoint [1]
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8 Weeks
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Secondary outcome [2]
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Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
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Assessment method [2]
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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.
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Timepoint [2]
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52 Weeks
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Secondary outcome [3]
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Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
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Assessment method [3]
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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.
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Timepoint [3]
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8 Weeks
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Secondary outcome [4]
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Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
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Assessment method [4]
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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.
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Timepoint [4]
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8 Weeks
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Secondary outcome [5]
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Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
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Assessment method [5]
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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.
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Timepoint [5]
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8 Weeks
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Secondary outcome [6]
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Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
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Assessment method [6]
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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.
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Timepoint [6]
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8 Weeks
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Secondary outcome [7]
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Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
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Assessment method [7]
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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.
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Timepoint [7]
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8 Weeks
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Secondary outcome [8]
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Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
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Assessment method [8]
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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.
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Timepoint [8]
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8 Weeks
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Secondary outcome [9]
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Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
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Assessment method [9]
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The change in fecal calprotectin level from baseline will be evaluated.
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Timepoint [9]
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52 Weeks
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Secondary outcome [10]
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Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
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Assessment method [10]
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VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
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Timepoint [10]
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52 Weeks
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Secondary outcome [11]
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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.
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Assessment method [11]
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VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
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Timepoint [11]
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52 Weeks
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Secondary outcome [12]
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Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
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Assessment method [12]
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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.
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Timepoint [12]
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52 Weeks
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Secondary outcome [13]
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Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
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Assessment method [13]
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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.
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Timepoint [13]
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52 Weeks
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Secondary outcome [14]
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Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
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Assessment method [14]
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To evaluate the impact of 2- and 8-week courses of VE202 on Inflammatory bowel disease (IBD) specific healthcare resource utilization.
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Timepoint [14]
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52 weeks
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Secondary outcome [15]
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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.
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Assessment method [15]
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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.
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Timepoint [15]
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52 Weeks
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Secondary outcome [16]
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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.
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Assessment method [16]
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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.
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Timepoint [16]
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52 Weeks
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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
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
10/11/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Mater Misericordiae Ltd and Mater Research Ltd - South Brisbane
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Recruitment hospital [3]
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St Vincent's Hospital Melbourne Department of Gastroenterology - Fitzroy
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Massachusetts
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United States of America
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New York
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Czechia
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Brno
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Czechia
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Olomouc
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Hungary
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Budapest
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Hungary
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Debrecen
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Lithuania
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Vilnius
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Netherlands
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Gelderland
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Netherlands
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Leiden
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Poland
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Lubelskie
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Mazowieckie
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Podkarpackie
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Pomorskie
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Wielkopolskie
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Katowice
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Poznan
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Lódzkie
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Ukraine
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Poltavska
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Ukraine
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Chernivtsi
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Ukraine
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Ivano-Frankivs'k
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Ukraine
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Kyiv
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Ukraine
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Luts'k
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Ukraine
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Ternopil'
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Ukraine
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Vinnytsia
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Ukraine
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Úzhgorod
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United Kingdom
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West Midlands
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Vedanta Biosciences, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT05370885
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Mary Garfield, MS
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Address
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Phone
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203.906.5693
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Fax
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Email
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[email protected]
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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
Download to PDF