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NCT01170286 · ClinicalTrials.gov registry record · Phase 1

Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy

A Phase 1 study, sponsored by DBV Technologies.

Completed
Registry status
Phase 1
Development phase
100
Enrollment target

NCT01170286: Completed Phase 1 study, sponsored by DBV Technologies.

NCT01170286 is a Phase 1 study that has completed, run by DBV Technologies. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01170286, a Phase 1 study, has completed, sponsored by DBV Technologies.

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target

Study Summary

The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.

Primary Outcome

The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1). Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the

Interventions

  • BIOLOGICAL Whole peanut extract
  • BIOLOGICAL Placebo formulation

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2010-07
Est. Completion 2012-02
Phase Phase 1
DBV Technologies

11 total trials

What the finished NCT01170286 record still lists

NCT01170286 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).

The record links to 0 conditions, and to 2 interventions - of which Whole peanut extract is the first listed.

NCT01170286 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01170286 about?

NCT01170286 is a clinical study titled "Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy". The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.

What is the current status of trial NCT01170286?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2010-07. Estimated completion is 2012-02.

What interventions are being tested in trial NCT01170286?

The interventions under investigation include: Whole peanut extract (BIOLOGICAL), Placebo formulation (BIOLOGICAL).

Who is sponsoring clinical trial NCT01170286?

This trial is sponsored by DBV Technologies, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01170286's enrollment target sits among peer trials

100 546th of 2000 higher than 1,411 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 NCT01170286, the US trial registry maintained by the National Library of Medicine. NCT01170286 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.