VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05370885
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vedanta Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis, Colitis, Ulcerative
Additional 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.

Arms & Interventions

Arms

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.

Interventions

Biological: - VE202

VE202 is a rationally defined, live biotherapeutic product for oral administration.

Drug: - Vancomycin Oral Capsule

Vancomycin is an antibiotic used to treat or prevent infection

Other: - VE202 Placebo

VE202 Placebo

Other: - Vancomycin Placebo

Vancomycin Placebo

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Lorraine Hughes, MS

Consortium02-ctinquiries@vedantabio.com

857.706.1427

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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