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RECRUITING

NCT06237452

PHASE3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Sponsor: Vedanta Biosciences, Inc.

View on ClinicalTrials.gov

Summary

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

852

Start Date

2024-05-20

Completion Date

2027-10

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Clostridium Difficile Clostridium Difficile Infections Clostridium Difficile Infection Recurrence Clostridioides Difficile Infection Clostridioides Difficile Infection Recurrence CDI C. Diff Infection Recurrent Clostridium Difficile Infection C.Difficile Diarrhea Diarrhea Infectious

Interventions

BIOLOGICAL

VE303

VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.

BIOLOGICAL

Placebo

Placebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product.

Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population): * Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population): * Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI * OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors: 1. Age ≥ 65 years 2. Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode 3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study 4. History of a prior CDI episode between 6 and 12 months prior to enrollment 5. Immunosuppression due to an underlying disease or its treatment 6. Has undergone solid organ or hematopoietic stem cell transplantation Key Inclusion Criteria (For enrollment in Stage 1 or 2): * The qualifying episode of CDI must meet all the following criteria: 1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days 2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI 3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory 4. Diarrhea considered unlikely to have another etiology * Prior to receiving any study medication, the participant should: 1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration. 2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days * Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing * Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization Key Exclusion Criteria (For both Stage 1 and Stage 2): * History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI * Known or suspected toxic megacolon or small bowel ileus at the time of randomization * History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis * Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode * Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug * Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study) * Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.) * Absolute neutrophil count (ANC) of \< 0.5 ×10\^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \< 1.0 × 10\^9 cells/L

Locations (215)

Metro Infectious Disease Consultants

Huntsville, Alabama, United States

Advanced Gastroenterology, P.C.

Chandler, Arizona, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

GI Alliance

Sun City, Arizona, United States

Om Research, LLC

Apple Valley, California, United States

Science 37 Inc (Remote/Home option)

Culver City, California, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

VA San Diego Healthcare System

San Diego, California, United States

North America Research Institute

San Dimas, California, United States

Clinical Trials Management Services

Thousand Oaks, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Connecticut Clinical Research Institute

Bristol, Connecticut, United States

Medical Research Center of Connecticut

Hamden, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Gastro Florida

Clearwater, Florida, United States

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, United States

Encore Borland-Groover Clinical Research

Jacksonville, Florida, United States

GI Pros Research

Naples, Florida, United States

Advanced Medical Research Center

Port Orange, Florida, United States

KM International Research Operation LLC

Saint Cloud, Florida, United States

James A. Haley Veterans' Hospital

Tampa, Florida, United States

International Center for Research

Tampa, Florida, United States

Summit Clinical Research, LLC

Athens, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Metro Infectious Disease Consultants

Decatur, Georgia, United States

Regional Infectious Diseases and Infusion Center, Inc.

La Grange, Georgia, United States

Gastrointestinal Specialists of Georgia

Marietta, Georgia, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

Metro Infectious Disease Consultants

Burr Ridge, Illinois, United States

NorthShore University Health System - Evanston Hospital

Evanston, Illinois, United States

GI Alliance

Gurnee, Illinois, United States

Innovative Clinical Research Center, LLC (ICRC)

Island Lake, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Gastroenterology Health Partners

New Albany, Indiana, United States

Deaconess GI Specialty Center

Newburgh, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

IDC Clinical Research, LLC

Wichita, Kansas, United States

Gastroenterology Health Partners

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

LTC Charles S. Kettles VA Medical Center

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

MNGI Digestive Health, PA

Plymouth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Delta Gastroenterology and Endoscopy Center

Southaven, Mississippi, United States

University of Missouri

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

St. Charles Clinical Research

Weldon Spring, Missouri, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Northwell Health Division of Infectious Diseases

Manhasset, New York, United States

NYU Grossman School of Medicine

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Manhattan Clinical Research, LLC

New York, New York, United States

Syracuse VA Medical Center

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Oklahoma City Veterans Affairs Healthcare System

Oklahoma City, Oklahoma, United States

Susquehanna Research Group - Gastroenterology

Harrisburg, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Guthrie Medical Group, PC

Sayre, Pennsylvania, United States

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

Lowcountry Infectious Diseases, P.A.

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Gastro One Research

Cordova, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

GI Alliance

Cedar Park, Texas, United States

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas, United States

University of Houston College of Pharmacy

Houston, Texas, United States

BioStar Clinical Research

Katy, Texas, United States

GI Alliance

Lubbock, Texas, United States

Simcare Medical Research, LLC

Sugar Land, Texas, United States

GI Alliance

Richmond, Virginia, United States

Seattle Infectious Disease Clinic

Seattle, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Melbourne Health

Parkville, Victoria, Australia

Erasme University Hospital - Infectiology Department

Anderlecht, Belgium

Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

CCIH - Consultoria em Controle de Infecção Hospitalar Ltda

Belo Horizonte, Minas Gerais, Brazil

Hospital Nossa Senhora das Graças

Curitiba, Paraná, Brazil

CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Medical Center Excelsior OOD, Base 1

Sofia, Sofia-Grad, Bulgaria

UMHAT Burgas AD

Burgas, Bulgaria

And 115 more locations on ClinicalTrials.gov

Clinical Research Directory

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (215)