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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03211247




Registration number
NCT03211247
Ethics application status
Date submitted
5/07/2017
Date registered
7/07/2017

Titles & IDs
Public title
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Scientific title
A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
Secondary ID [1] 0 0
EPITOPE
Universal Trial Number (UTN)
Trial acronym
EPITOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Part A Viaskin Peanut 250 mcg
Treatment: Other - Part A Viaskin Peanut 100 mcg
Treatment: Other - Part A Placebo
Treatment: Other - Part B Viaskin Peanut 250 mcg
Treatment: Other - Part B Placebo

Experimental: Part A Viaskin Peanut 250 mcg -

Experimental: Part A Viaskin Peanut 100 mcg -

Placebo comparator: Part A Placebo -

Experimental: Part B Viaskin Peanut 250 mcg -

Placebo comparator: Part B Placebo -


Treatment: Other: Part A Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily

Treatment: Other: Part A Viaskin Peanut 100 mcg
Viaskin Peanut 100 mcg, once daily

Treatment: Other: Part A Placebo
Placebo patch, once daily

Treatment: Other: Part B Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily

Treatment: Other: Part B Placebo
Placebo patch, once daily
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Treatment Responders at Month 12
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
Timepoint [1] 0 0
Month 12
Secondary outcome [2] 0 0
Change From Baseline in CRD of Peanut Protein to Month 12
Timepoint [2] 0 0
Baseline (Day 1) and Month 12
Secondary outcome [3] 0 0
ED of Peanut Protein at Month 12 Using ANCOVA Model
Timepoint [3] 0 0
Month 12
Secondary outcome [4] 0 0
Change From Baseline in ED of Peanut Protein to Month 12
Timepoint [4] 0 0
Baseline (Day 1) and Month 12
Secondary outcome [5] 0 0
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Timepoint [5] 0 0
Baseline (Day 1) and Month 12

Eligibility
Key inclusion criteria
Key

* Male or female from 1-3 years of age;
* Physician-diagnosed peanut allergy;
* Peanut-specific IgE level > 0.7 kU/L;
* Positive peanut SPT with a largest wheal diameter = 6 mm;
* Positive DBPCFC at = 300 mg peanut protein;

Key
Minimum age
1 Year
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled asthma;
* History of severe anaphylaxis to peanut;
* Prior immunotherapy to any food or other immunotherapy;
* Generalized severe dermatologic disease;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/04/2022
Sample size
Target
Accrual to date
Final
414
Recruitment in Australia
Recruitment state(s)
NSW,NWSQLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
The Women's and children's hospital - North Adelaide
Recruitment hospital [5] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
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United States of America
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Illinois
Country [8] 0 0
United States of America
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Indiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Metz
Country [24] 0 0
France
State/province [24] 0 0
Nice
Country [25] 0 0
France
State/province [25] 0 0
Paris
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France
State/province [26] 0 0
Vandoeuvre les nancy
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Germany
State/province [27] 0 0
Dresden
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Germany
State/province [28] 0 0
Frankfurt
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Germany
State/province [29] 0 0
Marburg
Country [30] 0 0
Ireland
State/province [30] 0 0
Cork
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
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United Kingdom
State/province [32] 0 0
London
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United Kingdom
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Manchester
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United Kingdom
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Sheffield
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United Kingdom
State/province [35] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DBV Technologies
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03211247