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Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

NCT02223182 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-11-20

Study results available
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Summary

The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.

Conditions

Interventions

BIOLOGICAL

Viaskin Milk 150 mcg

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.

BIOLOGICAL

Viaskin Milk 300 mcg

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.

BIOLOGICAL

Viaskin Milk 500 mcg

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.

BIOLOGICAL

Viaskin Placebo

Subjects epicutaneously administered daily (up to 24 hours application per day) 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
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-12-14
Completion
2020-12-22

Countries

  • United States
  • Canada

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 NCT02223182 on ClinicalTrials.gov