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

• Sponsor: DBV Technologies
• Information provided by (Responsible Party): DBV Technologies

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Biological: Viaskin Peanut 250mcg; Biological: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	356 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	December 2015
Actual Primary Completion Date :	August 18, 2017
Actual Study Completion Date :	August 18, 2017

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Percentage of treatment responders in each of the 2 screening ED strata [ Time Frame: Month 12 ]
2. Change from baseline of mean and median cumulative reactive dose of peanut protein [ Time Frame: Baseline and Month 12 ]
3. Change from baseline of mean and median eliciting dose of peanut protein [ Time Frame: Baseline and Month 12 ]

Other Outcome Measures:

1. Safety as assessed by Number of participants with treatment-related adverse events [ Time Frame: Through study completion, an average of 1 year ]
2. 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 ]
3. 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 ]
4. Peak exploratory flow (PEF) [ Time Frame: At screening and at Day1, Day 8, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
5. Composite measure of laboratory data (hematology and biochemistry analyses) [ Time Frame: At screening and at Month 3, Month 6 and Month 12 ]

Eligibility Criteria

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Ages Eligible for Study:	4 Years to 11 Years (Child)
Sexes Eligible for Study:	All
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

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Sponsors and Collaborators

DBV Technologies

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fleischer DM, Greenhawt M, Sussman G, Bégin P, Nowak-Wegrzyn A, Petroni D, Beyer K, Brown-Whitehorn T, Hebert J, Hourihane JO, Campbell DE, Leonard S, Chinthrajah RS, Pongracic JA, Jones SM, Lange L, Chong H, Green TD, Wood R, Cheema A, Prescott SL, Smith P, Yang W, Chan ES, Byrne A, Assa'ad A, Bird JA, Kim EH, Schneider L, Davis CM, Lanser BJ, Lambert R, Shreffler W. Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial. JAMA. 2019 Feb 22. doi: 10.1001/jama.2019.1113. [Epub ahead of print]

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Responsible Party:	DBV Technologies
ClinicalTrials.gov Identifier:	NCT02636699 History of Changes
Other Study ID Numbers:	PEPITES
First Posted:	December 22, 2015
Last Update Posted:	March 5, 2019
Last Verified:	February 2019

Additional relevant MeSH terms:

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Hypersensitivity; Peanut Hypersensitivity; Immune System Diseases	Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate