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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03013517




Registration number
NCT03013517
Ethics application status
Date submitted
2/01/2017
Date registered
6/01/2017
Date last updated
2/12/2020

Titles & IDs
Public title
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
Scientific title
Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
Secondary ID [1] 0 0
PEOPLE
Universal Trial Number (UTN)
Trial acronym
PEOPLE
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Viaskin Peanut 250µg

Experimental: Viaskin Peanut 250µg -


Treatment: Drugs: Viaskin Peanut 250µg
DBV712 250 µg, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) = 1,000 mg after 24 months of additional treatment in PEOPLE
Timepoint [1] 0 0
Month 24

Eligibility
Key inclusion criteria
* Subjects who completed the PEPITES study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
* Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Allergy Medical - Brisbane
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [3] 0 0
Children's Hospital Westmead - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Bonn
Country [18] 0 0
Germany
State/province [18] 0 0
Erlangen
Country [19] 0 0
Ireland
State/province [19] 0 0
Cork
Country [20] 0 0
Ireland
State/province [20] 0 0
Dublin

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 µg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.
Trial website
https://clinicaltrials.gov/study/NCT03013517
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03013517