VE202 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+71 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vedanta Biosciences, Inc.

Must not be taking: Probiotics, Herbal preparations

Disqualifiers: Crohn's disease, Indeterminate colitis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that any corticosteroid doses be stable for at least 4 weeks and other UC medication doses be stable for at least 8 weeks before joining. You cannot use probiotics or certain herbal medicines within 2 weeks before starting the trial.

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with ulcerative colitis over 3 months ago.

My corticosteroid dose has been the same for at least 4 weeks.

My ulcerative colitis medication doses have been stable for 8 weeks.

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Exclusion Criteria

Allergy to VE202 or any of its components

Allergy to vancomycin or any of its components

I haven't taken probiotics or herbal medicines in the last 2 weeks.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive VE202 or placebo for 8 weeks with Vancomycin pretreatment

8 weeks

Treatment Part 2

Participants receive VE202 or placebo for 2 weeks with Vancomycin pretreatment

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

VE202 (Microbiome Modulator)

Trial OverviewThe 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.

Participant Groups

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.