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Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection (CONSORTIUM)

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ClinicalTrials.gov Identifier: NCT03788434
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Vedanta Biosciences, Inc.

Brief Summary:
This study will evaluate the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Recurrence Clostridium Difficile Infection Clostridium Difficile CDI Drug: VE303 Drug: Placebo Phase 2

Detailed Description:

CONSORTIUM is a randomized, double-blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in prevention of subsequent CDI-associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo capsules will be taken orally for 14 days after completion of a course of standard of care antibiotics. The proportion of subjects experiencing a confirmed CDI recurrence, within 8 weeks after the first dose of study treatment, will be compared across the study arms to understand the effectiveness of VE303 in preventing rCDI.

The study will enroll approximately 146 to 300 subjects with a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must also have a positive C. difficile toxin stool sample and have responded to standard of care (SOC) antibiotic treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This Phase 2 study will help determine how safe and effective the study drug, VE303, is at preventing subsequent Clostridium difficile Infection (CDI)-associated diarrhea compared with placebo, following completion of at least 1 successful course of standard-of-care (SOC) antibiotics for subjects with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent CDI.

Patients in the study will be randomized into 3 arms in a 1:1:1 ratio of high dose VE303, low dose VE303, and placebo.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: To reduce potential bias and increase study data integrity, study participants, care providers, site investigators, and study outcomes assessors will all be masked to study treatment assignment.
Primary Purpose: Prevention
Official Title: A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: VE303 High Dose
Study subjects assigned the the high dose VE303 arm will take 10 capsules containing VE303 per day for 14 days.
Drug: VE303
VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.

Experimental: VE303 Low Dose
Study subjects assigned to the low dose VE303 arm will take 2 capsules containing VE303 per day for 14 days.
Drug: VE303
VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.

Placebo Comparator: Placebo
Study subjects assigned to the placebo dose arm will take placebo capsules each day for 14 days. The capsules will not contain any VE303.
Drug: Placebo
Placebo capsules contain micro-crystalline cellulose. They are visually identical to VE303 capsules. They will be taken by mouth for 14 days. Placebo capsules will not contain any VE303 Drug Product.




Primary Outcome Measures :
  1. Selection of Phase 3 dose for VE303 [ Time Frame: 24 weeks ]
    The primary objective is to determine the recommended VE303 Phase 3 dose regimen based on safety and efficacy, as indicated by the C difficile infection (CDI) recurrence rate.


Secondary Outcome Measures :
  1. Characterize VE303 colonization [ Time Frame: 24 weeks ]
    Secondary objective is to characterize VE303 colonization in the fecal microbiome after 14 days of treatment with VE303.

  2. Characterize Changes in the Fecal Microbiome [ Time Frame: 24 weeks ]
    Secondary objective is to characterize changes in the fecal microbiome after 14 days of treatment with VE303.


Other Outcome Measures:
  1. CDI recurrence week 8 [ Time Frame: 8 weeks after first study dose ]
    Proportion of subjects with CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).

  2. CDI recurrence week 4 [ Time Frame: 4 weeks after first study dose ]
    Proportion of subjects without CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment)

  3. CDI recurrence week 12 [ Time Frame: 12 weeks after first study dose ]
    Proportion of subjects without CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment)

  4. CDI recurrence week 24 [ Time Frame: 24 weeks after first study dose ]
    Proportion of subjects without CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment).

  5. Microbiota diversity [ Time Frame: 24 weeks ]
    Changes in fecal taxonomic composition after 14 days of blinded treatment with VE303.

  6. Taxonomic Composition [ Time Frame: 24 weeks ]
    Changes in fecal taxonomic composition after 14 days of blinded treatment with VE303.

  7. Metabolomic profile [ Time Frame: 24 weeks ]
    Changes in the fecal metabolomic profile, including short chain fatty acids and bile acids after 14 days of blinded treatment with VE303.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able and willing to provide written informed consent
  2. Subjects with a qualifying episode of CDI who have a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence (≥ 65 years of age)
  3. CDI symptoms must have started within 30 days (inclusive) prior to the day of randomization;
  4. The diarrhea is considered unlikely to have another etiology.
  5. Complete an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and up to 21 days of total duration
  6. Have a positive C. difficile stool
  7. Recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization.

Exclusion Criteria:

  1. History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4 weeks) that is not related to C. difficile infection within the 3 months prior to randomization.
  2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization.
  3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting, or ileus).
  4. Prior administration of genetically modified investigational live bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea
  5. History of administration of fecally-derived investigational live biotherapeutic products, or fecally-derived live bacterial isolates for CDI-associated diarrhea including fecal microbiota transplantation (FMT) within the last 6 months.
  6. Use of drugs that alter gut motility
  7. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization.
  8. Subjects with compromised immune system
  9. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within 3 months prior to randomization or any history of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen.
  10. History of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788434


Contacts
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Contact: Lorraine Hughes 857-706-1427 Consortium02-ctinquiries@vedantabio.com
Contact: Kelsey Brown, BA 857-706-1427 Consortium02-ctinquiries@vedantabio.com

  Show 36 Study Locations
Sponsors and Collaborators
Vedanta Biosciences, Inc.

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Responsible Party: Vedanta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03788434     History of Changes
Other Study ID Numbers: VE303-002
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vedanta Biosciences, Inc.:
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection
Clostridium Difficile
VE303
Consortium
Vedanta
CDI
C. Diff
CDiff
Clostridiodes Difficile Infection
Clostridiodes Difficile
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Recurrence
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections