Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy

NCT01675882 | Completed Phase 2 Results DMC

• 2 other identifiers: VIPES2011-002550-32
• Study Type: interventional
• Target: 221
• Locations: 5 countries
• Sites: 24

Brief Summary

The objectives of this dose-finding study for the treatment of peanut allergy are:

• To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment.
• To evaluate the safety of a long-term treatment with Viaskin Peanut.

Conditions

Peanut Allergy

Keywords

Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT)

Outcome Measures

Primary Outcomes (1)

• Percentage of Treatment Responders at Month 12; Analyzed in Overall Population

  A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).

  At Month 12

Secondary Outcomes (18)

• Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)

  At Month 12

• Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)

  At Month 12

• Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)

  At Month 12

• Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population

  At Month 12

• Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)

  At Month 12

Study Arms (4)

Viaskin Peanut 50 mcg

EXPERIMENTAL

Biological: Viaskin Peanut 50 mcg

Viaskin Peanut 100 mcg

EXPERIMENTAL

Biological: Viaskin Peanut 100 mcg

Viaskin Peanut 250 mcg

EXPERIMENTAL

Biological: Viaskin Peanut 250 mcg

Viaskin Placebo

PLACEBO COMPARATOR

Biological: Viaskin Placebo

Interventions

Viaskin Peanut 50 mcg BIOLOGICAL

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract

Viaskin Peanut 50 mcg

Viaskin Peanut 100 mcg BIOLOGICAL

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract

Viaskin Peanut 100 mcg

Viaskin Peanut 250 mcg BIOLOGICAL

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract

Viaskin Peanut 250 mcg

Viaskin Placebo BIOLOGICAL

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation

Viaskin Placebo

Eligibility Criteria

• Age: 6 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Peanut-allergic subjects between 6 and 55 years of age, with a well-documented medical history of systemic reactions after ingestion of peanut and currently following a strict peanut-free diet.
• Peanut-specific immunoglobulin E (IgE) level (Phadia CAP-system) \> 0.7 kU/L and a positive skin prick test to peanut with a largest wheal diameter ≥ 8 mm
• Positive double-blind placebo-controlled food challenge (DBPCFC) at ≤ 300 mg of peanut proteins: the eliciting dose of peanut proteins during the DBPCFC is capped at 300 mg, i.e. subjects must react to peanut before reaching or at the dose of 300 mg peanut proteins.
• Negative pregnancy test for women of childbearing potential. Females of childbearing age must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
• Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (2005) for subjects 9 years of age and above Subjects below 9 years of age can perform peak expiratory flow (PEF) instead.
• Willing to comply with all study requirements during their participation in the study.
• Provide signed informed consent and assent as appropriate.

You may not qualify if:

• Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence).
• Pregnancy or lactation.
• FEV1 \<80% of the predicted value at screening for subjects 9 years of age and above. PEF \< 80% of predicted for subjects below 9 years of age.
• Subjects who did not react at or below the dose of 300 mg of peanut proteins during the DBPCFC at screening.
• Known allergy or known hypersensitivity to placebo excipients either of the Viaskin patches or of the food challenge formulas.
• Subjects reacting objectively to the placebo formula at screening.
• Severe reaction during the screening food challenge, defined as need for intubation, hypotension persisting after epinephrine administration, or the need for more than two doses of epinephrine.
• Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges.
• Subjects treated with systemic long-acting corticosteroids (depot corticosteroids) within 12 weeks prior to the screening visit and/or systemic short-acting corticosteroid within 4 weeks prior to the screening visit or any systemic corticosteroid at screening.
• Subjects with asthma defined as follows:
• uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists;
• at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months;
• prior intubation for asthma in the past two years.
• Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
• Subjects undergoing any type of immunotherapy to any food within one year prior to the screening visit.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (24)

University of California, Rady Childrens Hospital

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Childrens' Hospital

Boston, Massachusetts, 02115, 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 Dallas

Dallas, Texas, 75235, United States

Location

ASTHMA, Inc.

Seattle, Washington, 98115, United States

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

Toronto, Ontario, M4V 1R2, Canada

Location

Centre de Recherche Appliquée en Asthme et Allergie de Québec

Sainte-Foy, Quebec, G1V 4M6, Canada

Location

Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

GCS des hôpitaux pédiatriques

Nice, 06200, France

Location

Hôpital Necker

Paris, 75743, France

Location

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Hôpitaux De Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Szpital Uniwersytecki nr2

Bydgoszcz, 85168, Poland

Location

Szpital Kliniczny UM

Lodz, 92213, Poland

Location

Related Publications (2)

• Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10. No abstract available.

  PMID: 30978404 DERIVED

• Sampson HA, Shreffler WG, Yang WH, Sussman GL, Brown-Whitehorn TF, Nadeau KC, Cheema AS, Leonard SA, Pongracic JA, Sauvage-Delebarre C, Assa'ad AH, de Blay F, Bird JA, Tilles SA, Boralevi F, Bourrier T, Hebert J, Green TD, Gerth van Wijk R, Knulst AC, Kanny G, Schneider LC, Kowalski ML, Dupont C. Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity: A Randomized Clinical Trial. JAMA. 2017 Nov 14;318(18):1798-1809. doi: 10.1001/jama.2017.16591.

  PMID: 29136445 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; 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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-09

Locations

US (10); NL (2); PL (2); FR (6); CA (4)