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Randomized 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 : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Vedanta Biosciences, Inc.

Brief Summary:
This study will evaluate the safety and efficacy of VE303 for participants with recurrent Clostridium difficile infection (rCDI).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Recurrence Clostridium Difficile Infection Clostridium Difficile 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 adult subjects with 1 or more recurrences of Clostridium difficile infection (CDI), including the current episode. 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 subsequent rCDI.

Approximately 146 subjects with: a history of CDI, diarrhea, a positive C. difficile toxin stool sample test, and who have responded to standard-of-care (SOC) antibiotic treatment, will be enrolled in the study. Participants will be randomly assigned, in a 1:1:1 ratio to 1 of 3 treatment arms (VE303 high dose, VE303 low dose, and placebo). Participants and their doctors will not know which treatment arm is assigned.


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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 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 Difficile Infection
Estimated Study Start Date : December 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:

  • Subjects must meet all of the following to be eligible:

    1. Able and willing to provide written informed consent prior to initiation of study treatment or of any study-specific procedures
    2. Subjects with any number of recurrent CDI episodes
    3. The current qualifying episode of rCDI must meet all of the following criteria:

      1. Second or greater occurrence of CDI in 6 months;
      2. New onset of ≥ 3 loose/unformed bowel movements within 24 hours for 2 consecutive days or > 8 loose/unformed bowel movements within 24 hours;
      3. Stool sample positive for C difficile toxin by central laboratory
      4. Prior to the first dose of study drug, completion of at least one Investigator's choice of SOC antibiotic therapy for CDI with a treatment duration of 10 to 21 days;
      5. Upon completion of SOC antibiotic therapy, successful clinical response defined as < 3 loose/unformed bowel movements within 24 hours for at least 2 consecutive days;

Exclusion Criteria:

  • Subjects meeting any of the following are not eligible:

    1. Subjects experiencing their first episode of CDI.
    2. Known or suspected toxic megacolon and/or known small bowel ileus.
    3. Prior administration of genetically modified and/or fecally-derived live biotherapeutic products
    4. Planned use of a proton-pump inhibitor (e.g., omeprazole, pantoprazole, etc.) more than once per day during the 14-day study drug administration period
    5. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization.
    6. White blood cell (WBC) count > 15,000 cells/mL, body temperature > 38.5°C, unless resolved by the time of randomization.
    7. Absolute neutrophil count of < 500 cells/mL3 on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC< 1000 cells/mL3, or compromised immune system (including corticosteroid use at doses higher than replacement amounts within 14 days prior to randomization).
    8. Current or immediate potential for mechanical ventilation or vasopressors for hemodynamic support.
    9. Major gastrointestinal surgery within 3 months prior to randomization or any history of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen.
    10. Female subject who is pregnant or breastfeeding.

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: Denise Tilton, BSN 857-259-6710 dtilton@vedantabio.com
Contact: Kelsey Brown, BA 857-706-1427 kbrown@vedantabio.com

Locations
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United States, Florida
Innovative Research of West Florida Recruiting
Clearwater, Florida, United States, 33756
Contact: Tracey Osborn    727-584-6368 ext 201    TraceyO@InnovativeResearchFL.com   
Principal Investigator: Miguel Trevino, MA         
Vital Pharma Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Luis Canete    786-666-0592    lcanete@vprfl.org   
Principal Investigator: Altagracia Victoria, MD         
United States, Virginia
Infectious Disease Associates of Central Virginia Infectious Disease Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Leigh McConaghy    434-947-3900 ext 2135    mcconaghyl@intravene.net   
Principal Investigator: Robert Brennan, MD         
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: December 27, 2018
Last Verified: December 2018
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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Recurrence
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections