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

Phase 3

Completed

• Conditions: Peanut Allergy
• Interventions: Biological: Viaskin Peanut 250mcg; Biological: Placebo

• Registration Number: NCT02636699
• Lead Sponsor: DBV Technologies

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 available

Study Timeline

• Study First Submitted: 2015-11-19
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-22
• Primary Completion: 2017-08-18
• Study Completion: 2017-08-18
• Disposition First Submitted: 2019-02-28
• Disposition First Submitted QC: 2019-02-28
• Disposition First Posted: 2019-03-05
• Status Verified: 2021-09
• Results First Submitted: 2021-09-17
• Results First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Results First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viaskin Peanut 250mcg	Viaskin Peanut 250mcg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population	At Month 12	The DBPCFCs to determine ED were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or; * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2).; Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.

Secondary Outcome Measures

Name	Time	Method
Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening ED Subgroup	At Month 12	The DBPCFCs to determine ED were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or; * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2).; Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented below. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed for each separate screening ED subgroup.
Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12	Baseline and Month 12	The CRD was calculated as the sum of all doses given (including any repeated and partial doses). The median CRD of peanut protein at baseline and Month 12 is presented. Analysis was performed using the modified baseline observation carried forward method to impute missing data at Month 12.

Trial Locations

Locations (31)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Gordon Sussman Clinical Research Inc.; 🇨🇦 Toronto, Ontario, Canada

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Our Lady's Children's Hospital; 🇮🇪 Dublin, Ireland

Boston Childrens' Hospital; 🇺🇸 Boston, Massachusetts, United States

Baylor College of Medicine - Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

ASTHMA, Inc.; 🇺🇸 Seattle, Washington, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

University of California, Rady Children's Hospital; 🇺🇸 San Diego, California, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Jaffe Food Allergy Institute; 🇺🇸 New York, New York, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

The University of North Carolina - Chapell Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Children's Hospital Westmead; 🇦🇺 Sydney, Australia

Princess Margaret Hospital for Children; 🇦🇺 Perth, Australia

Allergy Medical; 🇦🇺 Brisbane, Australia

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Clinical Investigations Unit; 🇮🇪 Cork, Ireland

Centre de Recherche Appliquée en Allergie de Québec (CRAAQ); 🇨🇦 Quebec, Canada

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Cheema Research Inc.; 🇨🇦 Mississauga, Ontario, Canada

Ottawa Allergy Asthma Research Institute; 🇨🇦 Ottawa, Ontario, Canada

CHUM & CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada

St.-Marien-Hospital; 🇩🇪 Bonn, Germany