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

Peanut Allergy Clinical Trial

— PEPITES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636699
• Other study ID #: PEPITES
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: August 18, 2017

Study information

• Verified date: September 2021
• Source: DBV Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: August 18, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• Viaskin Peanut 250mcg
Peanut extract cutaneous patch
• Placebo
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Locations

Country	Name	City	State
Australia	Allergy Medical	Brisbane
Australia	Princess Margaret Hospital for Children	Perth
Australia	Children's Hospital Westmead	Sydney
Canada	Cheema Research Inc.	Mississauga	Ontario
Canada	CHUM & CHU Sainte-Justine	Montréal	Quebec
Canada	Ottawa Allergy Asthma Research Institute	Ottawa	Ontario
Canada	Centre de Recherche Appliquée en Allergie de Québec (CRAAQ)	Quebec
Canada	Gordon Sussman Clinical Research Inc.	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	St.-Marien-Hospital	Bonn
Germany	Universitätsklinikum Erlangen	Erlangen
Ireland	Clinical Investigations Unit	Cork
Ireland	Our Lady's Children's Hospital	Dublin
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Boston Childrens' Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of North Carolina - Chapell Hill	Chapel Hill	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Baylor College of Medicine - Texas Children's Hospital	Houston	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Jaffe Food Allergy Institute	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California, Rady Children's Hospital	San Diego	California
United States	ASTHMA, Inc.	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
DBV Technologies

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Ireland, 

References & Publications (2)

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 — View Citation

Greenhawt M, Kim EH, Campbell DE, Green TD, Lambert R, Fleischer DM. Improvements in eliciting dose across baseline sensitivities following 12 months of epicutaneous immunotherapy (EPIT) in peanut-allergic children aged 4 to 11 years. J Allergy Clin Immun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time	Venous blood samples were drawn to assess peanut-specific IgE levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgE levels for each timepoint are presented. Relative change from baseline=100×(value at the visit-value at baseline)/value at baseline.	Baseline and Months 3, 6 and 12
Other	Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time	Venous blood samples were drawn to assess peanut-specific IgG4 levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgG4 levels for each timepoint are presented. Relative change from baseline=100×(value at the visit-value at baseline)/value at baseline.	Baseline and Months 3, 6 and 12
Primary	Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population	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.	At Month 12
Secondary	Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening ED Subgroup	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.	At Month 12
Secondary	Cumulative Reactive Dose (CRD) of Peanut Protein at 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.	Baseline and Month 12