RECRUITING

VE416 for Treatment of Food Allergy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy

Quick Facts

Study Start:2019-06-28

Study Completion:2024-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03936998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Wayne G Shreffler, MD, PhD

CONTACT

617-726-6147

wshreffler@mgh.harvard.edu

Jannat Gill, BDS, MPH

CONTACT

617-643-8683

jgill0@mgh.harvard.edu

Principal Investigator

Wayne G Shreffler, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Wayne G Shreffler, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-28

Study Completion Date2024-01-01

Study Record Updates

Study Start Date2019-06-28

Study Completion Date2024-01-01

Terms related to this study

Additional Relevant MeSH Terms

Peanut Allergy