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VE416 for Treatment of Food Allergy

NCT03936998 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-18

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Vancomycin plus VE416 before PNOIT

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

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

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

Sponsors & Collaborators

  • Vedanta Biosciences, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Wayne G Shreffler, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2023-11-01
Completion
2024-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936998 on ClinicalTrials.gov