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Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy (PEPITES)

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ClinicalTrials.gov Identifier: NCT02636699
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date March 5, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date August 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
Percentage of treatment responders in the overall population [ Time Frame: Month 12 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Percentage of treatment responders in each of the 2 screening ED strata [ Time Frame: Month 12 ]
  • Change from baseline of mean and median cumulative reactive dose of peanut protein [ Time Frame: Baseline and Month 12 ]
  • Change from baseline of mean and median eliciting dose of peanut protein [ Time Frame: Baseline and Month 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2015)
  • Safety as assessed by Number of participants with treatment-related adverse events [ Time Frame: Through study completion, an average of 1 year ]
  • Composite measure of physical examinations [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  • Composite measure of vital signs [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  • Peak exploratory flow (PEF) [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  • Composite measure of laboratory data (hematology and biochemistry analyses) [ Time Frame: At screening and at Month 3, Month 6 and Month 12 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Biological: Viaskin Peanut 250mcg
    Peanut extract cutaneous patch
    Other Name: DBV712
  • Biological: Placebo
    Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract
Study Arms  ICMJE
  • Experimental: Viaskin Peanut 250mcg
    Intervention: Biological: Viaskin Peanut 250mcg
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2016)
356
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2015)
330
Actual Study Completion Date  ICMJE August 18, 2017
Actual Primary Completion Date August 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  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 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 β2 agonist or with a combination therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled β2 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 β-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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Ireland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02636699
Other Study ID Numbers  ICMJE PEPITES
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DBV Technologies
Study Sponsor  ICMJE DBV Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DBV Technologies
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP