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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
Date last updated
16/12/2024

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
Assessment method [1] 0 0
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was =1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was =10 mg peanut protein and the ED was =300 mg peanut protein at the post-treatment DBPCFC 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
Assessment method [1] 0 0
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.
Timepoint [1] 0 0
Month 12
Secondary outcome [2] 0 0
Change From Baseline in CRD of Peanut Protein to Month 12
Assessment method [2] 0 0
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.
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
Assessment method [3] 0 0
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared 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
Assessment method [4] 0 0
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge.
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
Assessment method [5] 0 0
The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.
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
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
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
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
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
Country [26] 0 0
France
State/province [26] 0 0
Vandoeuvre les nancy
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Frankfurt
Country [29] 0 0
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
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Manchester
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Sheffield
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


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