VE416 for Treatment of Food Allergy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03936998
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
12 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Vancomycin plus VE416 before PNOIT — COMBINATION_PRODUCT
    Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
  • Vancomycin plus VE416 with PNOIT — COMBINATION_PRODUCT
    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
  • Placebo plus VE416 with PNOIT — COMBINATION_PRODUCT
    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
  • Placebo plus placebo with PNOIT — COMBINATION_PRODUCT
    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

Study Details

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.

Key Dates

Start date
Jun 28, 2019
Status verified
Oct 2023
Primary completion
Nov 1, 2023
Completion
Jan 1, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: vancomycin plus VE416 before PNOIT
    active vancomycin plus VE416 before PNOIT
  • Experimental: Vancomycin plus VE416 with PNOIT
    active vancomycin plus active VE416 with active PNOIT
  • Experimental: Placebo plus VE416 with PNOIT
    placebo vancomycin plus active VE416 with active VE416
  • Active Comparator: Placebo plus placebo with PNOIT
    placebo vancomycin and placebo VE416 with active peanut oral immunotherapy

Primary Outcome Measure

Primary Endpoint- Phase 1b [ Time Frame: 7 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Wayne G Shreffler, MD, PhD
[email protected]
617-643-9089
Jannat Gill, MPH
[email protected]
Wayne G Shreffler, MD, PhD (PRINCIPAL_INVESTIGATOR)
Chen Rosenberg, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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