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

NCT02636699 | Completed Phase 3 Results DMC

• 1 other identifier: PEPITES
• Study Type: interventional
• Target: 500
• Locations: 5 countries
• Sites: 31

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).

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population

  The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (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 Outcomes (2)

• Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup

  At Month 12

• Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12

  Baseline and Month 12

Other Outcomes (2)

• Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time

  Baseline and Months 3, 6 and 12

• Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time

  Baseline and Months 3, 6 and 12

Study Arms (2)

Viaskin Peanut 250mcg

EXPERIMENTAL

One Viaskin epicutaneous delivery system (patch) containing 250 µg of peanut protein applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months.

Biological: Viaskin Peanut 250mcg

Placebo

PLACEBO COMPARATOR

One Viaskin epicutaneous delivery system (patch) containing placebo applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months.

Biological: Placebo

Interventions

Viaskin Peanut 250mcg BIOLOGICAL

Peanut extract cutaneous patch

Also known as: DBV712

Viaskin Peanut 250mcg

Placebo BIOLOGICAL

Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Placebo

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female children aged 4 through 11 years;
• 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;
• Peanut-specific IgE level (ImmunoCAP system) \>0.7 kU/L;
• 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;
• Positive DBPCFC at ≤300 mg peanut protein.

You may not qualify if:

• History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence);
• Generalized dermatologic disease
• Diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as well as hereditary or idiopathic angioedema;
• 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;
• Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy;
• 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;
• 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;
• Prior or concomitant history of any immunotherapy to any food;
• 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;
• Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (31)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

University of California, Rady Children's Hospital

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Childrens' Hospital

Boston, Massachusetts, 02115, United States

Location

Jaffe Food Allergy Institute

New York, New York, 10029, United States

Location

The University of North Carolina - Chapell Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, 77030, United States

Location

ASTHMA, Inc.

Seattle, Washington, 98115, United States

Location

Allergy Medical

Brisbane, Australia

Location

Princess Margaret Hospital for Children

Perth, Australia

Location

Children's Hospital Westmead

Sydney, Australia

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V5H 3V4, Canada

Location

Cheema Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Ottawa Allergy Asthma Research Institute

Ottawa, Ontario, K1Y 4G2, Canada

Location

Gordon Sussman Clinical Research Inc.

Toronto, Ontario, M4V 1R2, Canada

Location

CHUM & CHU Sainte-Justine

Montreal, Quebec, H3T 1C4, Canada

Location

Centre de Recherche Appliquée en Allergie de Québec (CRAAQ)

Québec, QC G1V4M6, Canada

Location

Charité Universitätsmedizin Berlin

Berlin, D-13353, Germany

Location

St.-Marien-Hospital

Bonn, D-53115, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Clinical Investigations Unit

Cork, Ireland

Location

Our Lady's Children's Hospital

Dublin, Ireland

Location

Related Publications (4)

• Fleischer DM, Greenhawt M, Sussman G, Begin 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 Mar 12;321(10):946-955. doi: 10.1001/jama.2019.1113.

  PMID: 30794314 RESULT

• 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 Immunol Pract. 2020 Oct;8(9):3219-3221. doi: 10.1016/j.jaip.2020.05.030. Epub 2020 Jun 2. No abstract available.

  PMID: 32502548 RESULT

• Remington BC, Campbell DE, Green TD, Fleischer DM, Koppelman SJ. Post hoc analysis of epicutaneous immunotherapy for peanut allergy phase 3 results: Relevance for exposure through restaurant meals. Ann Allergy Asthma Immunol. 2021 Feb;126(2):208-209. doi: 10.1016/j.anai.2020.11.015. Epub 2020 Nov 28. No abstract available.

  PMID: 33259921 DERIVED

• Remington BC, Krone T, Kim EH, Bird JA, Green TD, Lack G, Fleischer DM, Koppelman SJ. Estimated risk reduction to packaged food reactions by epicutaneous immunotherapy (EPIT) for peanut allergy. Ann Allergy Asthma Immunol. 2019 Nov;123(5):488-493.e2. doi: 10.1016/j.anai.2019.08.007. Epub 2019 Aug 20.

  PMID: 31442495 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: DBV Technologies

clinicaltrials@dbv-technologies.com

33-1-55-42-78-78

Study Officials

• David M Fleischer, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: June 18, 2025
• Results First Posted: October 15, 2021

Record last verified: 2025-06

Locations

AU (3); US (17); IE (2); DE (3); CA (6)