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NCT03936998 · ClinicalTrials.gov registry record · Phase 1

VE416 for Treatment of Food Allergy

A Phase 1 study, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target

NCT03936998: Recruiting Phase 1 study, sponsored by Massachusetts General Hospital.

NCT03936998 is a Phase 1 study that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03936998, a Phase 1 study, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • COMBINATION_PRODUCT Vancomycin plus VE416 before PNOIT
  • COMBINATION_PRODUCT Vancomycin plus VE416 with PNOIT
  • COMBINATION_PRODUCT Placebo plus VE416 with PNOIT
  • COMBINATION_PRODUCT Placebo plus placebo with PNOIT

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2019-06-28
Est. Completion 2024-01-01
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What NCT03936998 shows while recruiting

NCT03936998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Vancomycin plus VE416 before PNOIT is the first listed.

NCT03936998 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03936998 about?

NCT03936998 is a clinical study titled "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 oral immunotherapy (PNOIT) alone.

What is the current status of trial NCT03936998?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2019-06-28. Estimated completion is 2024-01-01.

What interventions are being tested in trial NCT03936998?

The interventions under investigation include: Vancomycin plus VE416 before PNOIT (COMBINATION_PRODUCT), Vancomycin plus VE416 with PNOIT (COMBINATION_PRODUCT), Placebo plus VE416 with PNOIT (COMBINATION_PRODUCT), Placebo plus placebo with PNOIT (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT03936998?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03936998's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03936998, the US trial registry maintained by the National Library of Medicine. NCT03936998 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.