Save

VE202 in Patients with Mild-to-Moderate Ulcerative Colitis

PHASE2RECRUITING

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

Simpliy with AI

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

18 to 75 years of age

Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization

Active mild to moderate UC, as defined by the following: Disease that extends at least 15 cm from the anal verge; 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

Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC

If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization

Doses of other allowable UC medications must be stable for at least 8 weeks before randomization

Exclusion criteria

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

A known diagnosis of primary sclerosing cholangitis

Allergy to VE202 or any of its components

Allergy to vancomycin or any of its components

A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization

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)

Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization

Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)

Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer

Simplify with AI

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

Condition: Ulcerative Colitis, Colitis, Ulcerative
BIOLOGICAL: VE202 and other drugs
Concord, New South Wales, Australia and more
Sponsor: Vedanta Biosciences, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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. 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.
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.

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

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: VE202 in Patients with Mild-to-Moderate Ulcerative Colitis