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Microbiome Modulator

VE202 for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by Vedanta Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

18 to 75 years of age

Must not have

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

Diagnosis of any non-IBD diarrheal illness within 3 months prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial tests a new treatment for ulcerative colitis to see if it is safe, effective, and changes the gut bacteria.

Who is the study for?

This trial is for adults aged 18-75 with mild to moderate ulcerative colitis (UC) diagnosed at least 3 months ago. Participants must not have received certain UC treatments like biologics, and doses of other UC meds should be stable for 8 weeks. Exclusions include a history of Crohn's disease, allergies to VE202 or vancomycin, recent non-IBD diarrheal illnesses, use of probiotics or herbal preparations within 2 weeks before the trial, past fecal transplantations within 6 months, and any intestinal surgery except cholecystectomy or appendectomy.

What is being tested?

The Phase 2 study tests the safety and effectiveness of VE202 in patients with mild to moderate UC. It also looks at how it affects gut microbiota. Patients will receive either VE202 with a placebo that mimics vancomycin or vice versa; some may get both placebos as controls.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with clinical trials involving new drugs for UC might include gastrointestinal discomforts such as nausea and bloating, potential allergic reactions to components in the drug formulation, headaches, fatigue and possible changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with ulcerative colitis over 3 months ago.

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I am between 18 and 75 years old.

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My ulcerative colitis affects an area at least 15 cm from the anal verge.

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My ulcerative colitis is moderate to severe, with significant inflammation and bleeding.

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I have never taken biologic drugs or specific inhibitors for ulcerative colitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my intestines, but not for gallbladder or appendix removal.

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I have had a diarrheal illness that is not IBD within the last 3 months.

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I have been diagnosed with Crohn's disease or indeterminate colitis.

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I have been diagnosed with primary sclerosing cholangitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.

Secondary study objectives

Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.

Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.

Change in fecal calprotectin levels after 2- and 8-week courses of VE202.

+13 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.Experimental Treatment4 Interventions

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.

Group II: Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

FDA approved

0 / 9Eligibility criteria met