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VE303 for preventing recurrent Clostridioides difficile infections

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

Phase 3 Interventional Vedanta Biosciences, Inc. · NCT06237452

This study is testing a new treatment called VE303 to see if it can help prevent Clostridioides difficile infections from coming back in people who are at high risk.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment852 (estimated)
Ages12 Years and up
SexAll
SponsorVedanta Biosciences, Inc. Industry-sponsored
Drugs / interventionsbezlotoxumab
Locations215 sites (Huntsville, Alabama and 214 other locations)
Trial IDNCT06237452 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of VE303 in preventing the recurrence of Clostridioides difficile infections (CDI) in participants. It includes two stages: one for individuals with recurrent CDI and another for high-risk primary CDI patients. Participants will receive either VE303 or a placebo for 14 days, and the primary outcome will be the CDI recurrence rate at Week 8. The study aims to provide insights into a potential new treatment option for those at risk of CDI recurrence.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 and older with a history of recurrent CDI or high-risk primary CDI, particularly those over 75 years or with specific risk factors.

Not a fit: Patients without a history of CDI or those who do not meet the age and risk factor criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of Clostridioides difficile infections in at-risk patients.

How similar studies have performed: Other studies have shown promise in using similar approaches for CDI prevention, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Huntsville, Alabama and 214 other locations

+165 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Clostridium DifficileClostridium Difficile InfectionsClostridium Difficile Infection RecurrenceClostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceCDIC. Diff InfectionRecurrent Clostridium Difficile Infection
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.