VE416 for Treatment of Food Allergy

NCT03936998 | Unknown Phase 1 FDA Drug

• 1 other identifier: 2019P000886
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint- Phase 1b

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  7 weeks

• Primary Endpoint- Phase II

  The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1

  23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC

Secondary Outcomes (2)

• Secondary Endpoint- Efficacy

  54 weeks

• Secondary Endpoint- Safety

  54 weeks

Study Arms (4)

vancomycin plus VE416 before PNOIT

EXPERIMENTAL

active vancomycin plus VE416 before PNOIT

Combination Product: Vancomycin plus VE416 before PNOIT

Vancomycin plus VE416 with PNOIT

EXPERIMENTAL

active vancomycin plus active VE416 with active PNOIT

Combination Product: Vancomycin plus VE416 with PNOIT

Placebo plus VE416 with PNOIT

EXPERIMENTAL

placebo vancomycin plus active VE416 with active VE416

Combination Product: Placebo plus VE416 with PNOIT

Placebo plus placebo with PNOIT

ACTIVE COMPARATOR

placebo vancomycin and placebo VE416 with active peanut oral immunotherapy

Combination Product: Placebo plus placebo with PNOIT

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 before 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

Vancomycin plus VE416 with 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 VE416 with 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

Placebo plus placebo with PNOIT

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Vedanta Biosciences, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994.

  PMID: 33463542 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Wayne G Shreffler, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Food Allergy Center

Model 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.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 3, 2019
• Study Start: June 28, 2019
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)