VE416 for Peanut Allergy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called VE416 for individuals with peanut allergies. It compares different methods of using VE416, including with or without a common treatment known as peanut oral immunotherapy (PNOIT), to determine the most effective approach. The goal is to identify a safe and effective way to help manage peanut allergies. Individuals with a documented peanut allergy who can undergo an oral food challenge may be suitable candidates for this study. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and to measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, such as beta blockers, angiotensin converting enzyme inhibitors, and monoamine oxidase inhibitors. Additionally, you should not have used systemic immunomodulatory treatments or biologics with an immune target in the past 6 months.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that VE416, when used with peanut oral immunotherapy (PNOIT), is under study for its safety and effectiveness in treating peanut allergies. In earlier studies, researchers combined VE416 with vancomycin, an antibiotic, to assess its potential in improving peanut allergy treatment.
Safety data from past research indicates that VE416 is generally well-tolerated. Some mild side effects have been reported, but no serious problems have been linked to the treatment so far. Since this trial is in the early stages, the treatment has passed initial safety checks in humans. However, researchers continue to closely monitor it to ensure safety for all participants.12345Why are researchers excited about this trial's treatments?
Researchers are excited about VE416 for peanut allergy because it introduces a novel approach by combining probiotics with oral immunotherapy. Unlike traditional treatments that primarily rely on gradual exposure to allergens, VE416 leverages the gut microbiome to enhance immune tolerance to peanuts. By incorporating active vancomycin and probiotic strains, this treatment aims to improve efficacy and potentially reduce the risk of allergic reactions. This innovative mechanism could offer a safer, more effective alternative for individuals with peanut allergies.
What evidence suggests that this trial's treatments could be effective for peanut allergy?
Research shows that VE416 may help treat peanut allergies. In this trial, participants will receive different combinations of VE416, vancomycin, and peanut oral immunotherapy (PNOIT) to assess their effectiveness. Studies have found that using VE416 with a small amount of PNOIT can help the body become more tolerant to peanuts. VE416 changes gut bacteria, which may help lessen allergic reactions. Early results suggest this method could effectively manage food allergies, including peanut allergies. While more research is needed, these initial findings offer promise for those with peanut allergies seeking new treatment options.13678
Who Is on the Research Team?
Wayne G Shreffler, MD, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for people aged 12-55 with a confirmed peanut allergy, who can swallow capsules and are not pregnant or breastfeeding. They shouldn't have immune deficiencies, severe anaphylaxis history, poorly-controlled asthma, or be on certain heart medications or other immunomodulatory treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Treatment
Participants receive treatment to assess safety and treatment-related adverse events
Phase II Treatment
Participants receive VE416 in combination with vancomycin and peanut oral immunotherapy to evaluate the maximum tolerated dose of peanut protein
Post-Phase II Maintenance
Participants continue with maintenance treatment following Phase II
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VE416
Trial Overview
The study tests VE416 as either a pretreatment or alongside low-dose peanut oral immunotherapy (PNOIT). Participants will be randomly assigned to one of four groups: some getting the real treatment plus PNOIT and others getting placebo versions.
How Is the Trial Designed?
active vancomycin plus VE416 before PNOIT
active vancomycin plus active VE416 with active PNOIT
placebo vancomycin plus active VE416 with active VE416
placebo vancomycin and placebo VE416 with active peanut oral immunotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Vedanta Biosciences, Inc.
Industry Sponsor
Citations
NCT03936998 | VE416 for Treatment of Food Allergy
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 ...
Feast for thought: A comprehensive review of food allergy ...
As for identification of patients who react to low doses of allergen, the BAT showed 70% sensitivity, 72% specificity, and 71% accuracy. In a PA study, the BAT ...
3.
aging.networkofcare.org
aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03936998?keyword=%22Peanut%20Allergy%22San Mateo Clinical Trial VE416 for Treatment of Food Allergy
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose ...
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT03936998/ve416-for-treatment-of-food-allergyVE416 for Treatment of Food Allergy
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to ...
VE-416 - Drug Targets, Indications, Patents
VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy. 100 Clinical Results associated with VE-416. Login to view more data.
Adults and adolescents (ages 12-55) needed for a peanut ...
We want to learn more about a live biotherapeutic product, VE416, with peanut oral immunotherapy to see if this will help people with peanut allergies. Why it ...
New Insights in Therapy for Food Allergy - PMC
In addition, another study (NCT03936998) is determining if VE416 in combination with vancomycin (an antibiotic) could be used as OIT in peanut allergy patients.
8.
biospace.com
biospace.com/vedanta-biosciences-announces-first-patient-enrolled-in-ve416-phase-1b-2-food-allergy-clinical-studyVedanta Biosciences Announces First Patient Enrolled in ...
The primary endpoints are safety of VE416 and amount of peanut protein tolerated during a double-blind, placebo-controlled food challenge ...
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