Recruiting

Phase 1

Phase 2

VE416VE416 for Treatment of Food Allergy

Sponsor:

Massachusetts General Hospital

Code:

NCT03936998

Conditions

Peanut Allergy

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

Interventions

Vancomycin plus VE416 before PNOIT

Vancomycin plus VE416 with PNOIT

Placebo plus VE416 with PNOIT

Placebo plus placebo with PNOIT

Study Details

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.

Conditions

Peanut Allergy

Study ID

NCT03936998

Start date

Jun 28, 2019

Status verified date

Oct, 2023

Completion date

Jan 1, 2024

Anticipated

Primary completion date

Nov 1, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Vancomycin plus VE416 before PNOIT

Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT

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

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

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 measure

Primary Endpoint- Phase 1b [ Time Frame: 7 weeks ]
Primary Endpoint- Phase II [ Time Frame: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC ]

Central Contacts and Locations

Central contacts

Wayne G Shreffler, MD, PhD

617-726-6147 wshreffler@mgh.harvard.edu

Jannat Gill, BDS, MPH

617-643-8683 jgill0@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Wayne G Shreffler, MD, PhD

617-643-9089 WSHREFFLER@mgh.harvard.edu

Jannat Gill, MPH

jgill0@mgh.harvard.edu

Principal Investigator:

Wayne G Shreffler, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2023-10-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.