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Trial record 1 of 1 for:    NCT03936998
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VE416 for Treatment of Food Allergy

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ClinicalTrials.gov Identifier: NCT03936998
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Vedanta Biosciences, Inc.
Information provided by (Responsible Party):
Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital

Brief Summary:
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.

Condition or disease Intervention/treatment Phase
Peanut Allergy Combination Product: Vancomycin plus VE416 before PNOIT Combination Product: Vancomycin plus VE416 with PNOIT Combination Product: Placebo plus VE416 with PNOIT Combination Product: Placebo plus placebo with PNOIT Phase 1 Phase 2

Detailed Description:

In this research study the investigators want to learn more about an investigational medicine called VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy. VE416 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines and in combination with peanut flour may help to prevent participants from getting sick (upset stomach, breathing problems, and skin problems) when participants come into contact with peanuts.

The investigators are doing this research study to find out if VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy can help people with peanut allergy. VE416 is a consortium of commensal, or "friendly", dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines. The investigators also want to find out if VE416 with peanut oral immunotherapy is safe to take without causing too many side effects.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: vancomycin plus VE416 before PNOIT
active vancomycin plus VE416 before PNOIT
Combination Product: Vancomycin plus VE416 before PNOIT
Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT

Experimental: Vancomycin plus VE416 with PNOIT
active vancomycin plus active VE416 with active PNOIT
Combination Product: Vancomycin plus VE416 with PNOIT
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT

Experimental: Placebo plus VE416 with PNOIT
placebo vancomycin plus active VE416 with active VE416
Combination Product: Placebo plus VE416 with PNOIT
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT

Active Comparator: Placebo plus placebo with PNOIT
placebo vancomycin and placebo VE416 with active peanut oral immunotherapy
Combination Product: Placebo plus placebo with PNOIT
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT




Primary Outcome Measures :
  1. Primary Endpoint- Phase 1b [ Time Frame: 7 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Primary Endpoint- Phase II [ Time Frame: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC ]
    The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1


Secondary Outcome Measures :
  1. Secondary Endpoint- Efficacy [ Time Frame: 54 weeks ]
    The percentage of patients tolerating 600 mg (1030 mg cumulative) at DBPCFC1 without treatment

  2. Secondary Endpoint- Safety [ Time Frame: 54 weeks ]
    The occurrence of treatment related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People of all ethnic/racial/gender groups aged 12-55 years old with a documented medical history of peanut allergy.
  • Evidence of peanut-specific IgE by either: positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE _5 kU/L at screening visit.
  • Ara h 2 specific IgE >0.35 kU/L at screening visit.
  • Willing to sign informed consent or whose parent or legal guardian is willing to sign the consent form (age appropriate).
  • Willing to sign the assent form, if age appropriate.
  • (For continuation into Phase II only) Allergic reaction requiring treatment at _ 100 mg dose of peanut protein during Entry Challenge.

Exclusion Criteria:

  • History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 <92% during reaction), documented hypotension (documented systolic BP >30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
  • Severe or Moderate asthma as defined using the severity criteria of the current NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
  • Poorly-controlled asthma as defined by FEV1 <80% or any of the following symptoms: nighttime awakening >2 days/week or rescue medication use >2 days / week.
  • Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
  • Inability to cooperate with and/or perform oral food challenge procedures.
  • Inability to swallow size 0 capsule
  • Primary Immune Deficiency
  • Allergy to oat confirmed by skin prick testing and history
  • Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
  • Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
  • Hematocrit <0.36 for adult females or <0.38 for adult males Weight <23 kg
  • Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab.
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.

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): NCT03936998


Contacts
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Contact: Wayne G Shreffler, MD, PhD 617-726-6147 wshreffler@mgh.harvard.edu
Contact: Cynthia A Esteban, NP, MPH 617-724-2081 cesteban@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Wayne G Shreffler, MD, PhD    617-726-0693    WSHREFFLER@mgh.harvard.edu   
Contact: Cynthia Esteban, NP    617-724-2081    CESTEBAN@mgh.harvard.edu   
Principal Investigator: Wayne G Shreffler, MD, PhD         
Principal Investigator: Joyce Hsu, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Vedanta Biosciences, Inc.
Investigators
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Principal Investigator: Wayne G Shreffler, MD, PhD Massachusetts General Hospital

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Responsible Party: Wayne G. Shreffler, MD, PhD, Director of the Food Allergy Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03936998     History of Changes
Other Study ID Numbers: 2019P000886
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents