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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02636699




Registration number
NCT02636699
Ethics application status
Date submitted
19/11/2015
Date registered
22/12/2015
Date last updated
5/03/2019

Titles & IDs
Public title
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
Scientific title
A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children
Secondary ID [1] 0 0
PEPITES
Universal Trial Number (UTN)
Trial acronym
PEPITES
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
Other interventions - Viaskin Peanut 250mcg
Other interventions - Placebo

Experimental: Viaskin Peanut 250mcg -

Placebo Comparator: Placebo -


Other interventions: Viaskin Peanut 250mcg
Peanut extract cutaneous patch

Other interventions: Placebo
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of treatment responders in the overall population - A subject is defined as a treatment responder if:
The initial eliciting dose (ED) was >10 mg peanut protein and the ED is =1,000 mg peanut protein at the post treatment double-blind placebo controlled food challenge (DBPCFC), or
The initial eliciting dose (ED) was =10 mg and the ED is =300 mg peanut protein at the post-treatment DBPCFC.
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Percentage of treatment responders in each of the 2 screening ED strata
Timepoint [1] 0 0
Month 12
Secondary outcome [2] 0 0
Change from baseline of mean and median cumulative reactive dose of peanut protein
Timepoint [2] 0 0
Baseline and Month 12
Secondary outcome [3] 0 0
Change from baseline of mean and median eliciting dose of peanut protein
Timepoint [3] 0 0
Baseline and Month 12

Eligibility
Key inclusion criteria
Main

1. Male or female children aged 4 through 11 years;

2. Physician-diagnosis of peanut allergy or children with a well documented medical
history of IgE-mediated symptoms after ingestion of peanut and currently following a
strict peanut-free diet, but without a physician diagnosis;

3. Peanut-specific IgE level (ImmunoCAP system) >0.7 kU/L;

4. Positive peanut skin prick test (SPT) with a largest wheal diameter:

- =6 mm for children 4 through 5 years of age at Visit 1,

- =8 mm for children 6 years and above at Visit 1;

5. Positive DBPCFC at =300 mg peanut protein.

Main
Minimum age
4 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of severe anaphylaxis to peanut with any of the following symptoms:
hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or
incontinence);

2. Generalized dermatologic disease

3. Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as
well as hereditary or idiopathic angioedema;

4. Diagnosis of asthma that fulfills any of the following criteria:

- Uncontrolled persistent asthma as defined by National Asthma Education and
Prevention Program Asthma guidelines 2007 or by Global Initiative for Asthma
guidelines 2015,

- Asthma treated with either a high daily high dose of inhaled corticosteroid or
with a combination therapy of a medium or high daily dose of inhaled
corticosteroid with a long acting inhaled ß2 agonist or with a combination
therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled
ß2 agonist. Asthmatic subjects treated with a medium daily dose of inhaled
corticosteroids are eligible. Intermittent asthmatic subjects who require
intermittent use of inhaled corticosteroids for rescue are also eligible,

- Two or more systemic corticosteroid courses for asthma in the past year or 1 oral
corticosteroid course for asthma within 3 months prior to Visit 1, or during
screening period,

- Prior intubation/mechanical ventilation for asthma within 1 year prior to Visit
1, or during screening;

5. Receiving ß-blocking agents, angiotensin-converting enzyme inhibitors,
angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant
therapy;

6. Received anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or
any biologic immunomodulatory therapy within 1 year prior to Visit 1, during screening
period or during study participation;

7. Use of systemic long-acting corticosteroids within 12 weeks prior to Visit 1 and/or
use of systemic short-acting corticosteroids within 4 weeks prior to Visit 1 or during
screening;

8. Prior or concomitant history of any immunotherapy to any food;

9. Receiving or planning to receive any aeroallergen immunotherapy during their
participation in the study. Aeroallergen immunotherapy must be discontinued at the
time of Visit 1;

10. Any disorder in which epinephrine is contraindicated such as coronary artery disease,
uncontrolled hypertension, or serious ventricular arrhythmias.

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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein
to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age
after a 12-month treatment by epicutaneous immunotherapy (EPIT).
Trial website
https://clinicaltrials.gov/show/NCT02636699
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
Other publications