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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by DBV Technologies
Sponsor:
Information provided by (Responsible Party):
DBV Technologies
ClinicalTrials.gov Identifier:
NCT02636699
First received: November 19, 2015
Last updated: February 8, 2016
Last verified: February 2016
  Purpose
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).

Condition Intervention Phase
Peanut Allergy
Biological: Viaskin Peanut 250mcg
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by DBV Technologies:

Primary Outcome Measures:
  • Percentage of treatment responders in the overall population [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Percentage of treatment responders in each of the 2 screening ED strata [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change from baseline of mean and median cumulative reactive dose of peanut protein [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change from baseline of mean and median eliciting dose of peanut protein [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety as assessed by Number of participants with treatment-related adverse events [ Time Frame: Through study completion, an average of 1 year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Peak exploratory flow (PEF) [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ] [ Designated as safety issue: Yes ]
  • Composite measure of laboratory data (hematology and biochemistry analyses) [ Time Frame: At screening and at Month 3, Month 6 and Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: December 2015
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viaskin Peanut 250mcg Biological: Viaskin Peanut 250mcg
Peanut extract cutaneous patch
Other Name: DBV712
Placebo Comparator: Placebo Biological: Placebo
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02636699

  Show 28 Study Locations
Sponsors and Collaborators
DBV Technologies
  More Information

No publications provided

Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT02636699     History of Changes
Other Study ID Numbers: PEPITES 
Study First Received: November 19, 2015
Last Updated: February 8, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
Ireland: Health Products Regulatory Authority
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on February 11, 2016