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Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy

NCT01675882 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2021-10-27

Study results available
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Summary

The objectives of this dose-finding study for the treatment of peanut allergy are:

* To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment.
* To evaluate the safety of a long-term treatment with Viaskin Peanut.

Conditions

Interventions

BIOLOGICAL

Viaskin Peanut 50 mcg

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract

BIOLOGICAL

Viaskin Peanut 100 mcg

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract

BIOLOGICAL

Viaskin Peanut 250 mcg

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract

BIOLOGICAL

Viaskin Placebo

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation

Sponsors & Collaborators

  • DBV Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Canada
  • France
  • Netherlands
  • Poland

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 NCT01675882 on ClinicalTrials.gov