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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 details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-05-08
Primary completion: 2025-07-31
Study completion finish: 2025-11-10
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05370885
Intervention or treatment
BIOLOGICAL: VE202
DRUG: Vancomycin Oral Capsule
OTHER: VE202 Placebo
OTHER: Vancomycin Placebo
Conditions
- • Ulcerative Colitis
- • Colitis, Ulcerative
Find a site
Closest Location:
Concord Repatriation General Hospital
Research sites nearby
Select from list below to view details:
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
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?
Participant Group/Arm | Intervention/Treatment |
---|---|
OTHER: Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
| BIOLOGICAL: VE202
|
OTHER: Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
| BIOLOGICAL: VE202
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 |
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