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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DBV Technologies
ClinicalTrials.gov Identifier:
NCT01675882
First received: August 17, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.

Condition Intervention Phase
Peanut Allergy
Biological: Viaskin Peanut 50 mcg
Biological: Viaskin Peanut 100 mcg
Biological: Viaskin Peanut 250 mcg
Biological: Viaskin Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Trial to Study the Viaskin Peanut's Efficacy and Safety for Treating Peanut Allergy in Children and Adults.

Resource links provided by NLM:


Further study details as provided by DBV Technologies:

Primary Outcome Measures:
  • The increase in the threshold dose of peanut protein after treatment assessed by double-blind, placebo-controlled food challenges (DBPCFC) before and after 12 months of treatment [ Time Frame: From baseline to end of treatment (12 months) ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the percentage of treatment responders for each active treatment compared to placebo. A treatment responder is defined as a subject with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the double-blind, placebo-controlled peanut challenge after 12 months of treatment or a subject with a ≥ 10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose.


Secondary Outcome Measures:
  • The mean eliciting doses of peanut proteins at Month 12 in the 50 mcg, 100 mcg and 250 mcg groups versus the placebo group [ Time Frame: End of treatment (12 months) ] [ Designated as safety issue: No ]
  • The mean cumulative reactive dose of peanut proteins at Month 12 in the 50 mcg, 100 mcg and 250 mcg groups versus the placebo group. [ Time Frame: End of treatment (12 months) ] [ Designated as safety issue: No ]
  • The change in the severity of symptoms elicited during the peanut DBPCFCs from baseline to Month 12 for each treatment group. [ Time Frame: From baseline to end of treatment (12 months) ] [ Designated as safety issue: No ]
  • Time of appearance of the very first objective symptom during the DBPCFC at Month 12 in the 50 mcg, 100 mcg and 250 mcg groups versus the placebo group. [ Time Frame: End of treatment (12 months) ] [ Designated as safety issue: No ]
  • The change in peanut end point titration by skin prick testing at baseline and at Months 3, 6 and 12. [ Time Frame: From baseline to month 3, to month 6 and to month 12 (end of treatment) ] [ Designated as safety issue: No ]
  • The change in peanut-specific IgE, and immunoglobulin G subtype 4 (IgG4) at baseline and at Months 3, 6 and 12 [ Time Frame: From baseline to month 3, to month 6 and to month 12 (end of treatment) ] [ Designated as safety issue: No ]
  • The correlation between the presence of peanut protein component(s) and response to treatment. [ Time Frame: From baseline to end of treatment (12 months) ] [ Designated as safety issue: No ]
  • The mean fold reduction of basophil activation, assessed by CD203c expression, at Months 3, 6 and 12. These results will be correlated with the primary efficacy criterion. [ Time Frame: From baseline to month 3, to month 6 and to month 12 (end of treatment) ] [ Designated as safety issue: No ]
  • Primary efficacy endpoint in each age stratum. [ Time Frame: From baseline to end of treatment (12 months) ] [ Designated as safety issue: No ]
    In each age stratum, the percentage of treatment responders for each active treatment compared to placebo will be calculated. A treatment responder is defined as a subject with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the double-blind, placebo-controlled peanut challenge after 12 months of treatment or a subject with a ≥ 10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose.

  • Secondary efficacy endpoints in each age stratum for the mean eliciting dose in each treatment group and time of appearance of the 1st objective symptom. [ Time Frame: End of treatment (12 months) ] [ Designated as safety issue: No ]
    In each age stratum, the mean eliciting doses of peanut proteins and the time of appearance of the very first objective symptom during the DBPCFC will be assessed at Month 12 in the 50 mcg, 100 mcg and 250 mcg groups versus the placebo group.

  • Secondary efficacy endpoints in each age stratum for the change in peanut-specific IgE and in IgG4 and the mean fold reduction of basophil activation of CD203c expression [ Time Frame: From baseline to month 3, to month 6 and to month 12 (end of treatment) ] [ Designated as safety issue: No ]
    In each age stratum, the change in peanut-specific IgE, and immunoglobulin G subtype 4 (IgG4) and the mean fold reduction of basophil activation as assessed by CD203c expression will be evaluated at Months 3, 6 and 12.

  • Adverse events (AEs) by system organ class and relatedness to treatment(all subjects and by age strata). [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]
  • Incidence, duration and severity of local treatment-induced AEs as assessed by the subjects (all subjects and by age strata). [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]
  • Systemic allergic symptoms and relatedness to treatment(all subjects and by age strata). [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]
  • Serious AEs (SAEs) and relatedness to treatment (all subjects and by age strata) [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]
  • Severity of AEs or SAEs elicited during the study and during the DBPCFCs at entry and after treatment (all subjects). [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]
  • Laboratory data(all subjects), spirometry results (all subjects and by age strata). [ Time Frame: At baseline, month 3, month 6 and month 12 (end of treatment) ] [ Designated as safety issue: Yes ]
  • Physical examinations and vital signs (all subjects). [ Time Frame: At each of the 12 study visits (3 visits during the up to 1-month screening period, 7 visits during the 12-month treament period and 2 visits during the up to 3-week follow-up period) ] [ Designated as safety issue: Yes ]
  • Safety sub-analysis in subjects with mutations in the filaggrin gene versus wild type subjects [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]
    This safety sub-analysis will be performed on the following parameters: Incidence, duration and severity of local treatment-induced AEs, systemic allergic symptoms related to treatment, SAEs related to treatment, spirometry results.


Other Outcome Measures:
  • Collection of any specific reaction triggered by an accidental consumption of peanut and the conditions around that accidental consumption [ Time Frame: throughout the treatment period (12 months) and the follow-up period (up to 3 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 221
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viaskin Peanut 50 mcg Biological: Viaskin Peanut 50 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
Experimental: Viaskin Peanut 100 mcg Biological: Viaskin Peanut 100 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
Experimental: Viaskin Peanut 250 mcg Biological: Viaskin Peanut 250 mcg
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
Placebo Comparator: Viaskin Placebo Biological: Viaskin Placebo
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation

Detailed Description:

Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. So far, there is no approved treatment of peanut allergy. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.

DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented

The VIPES study is a 12-month double-blind, placebo-controlled,randomized trial to study the efficacy and safety of Viaskin Peanut in subjects from 6 to 55 years old with a history of immediate hypersensitive reaction to peanut protein.

The trial will be conducted at sites with investigators and staff trained and experienced in the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or pediatric subjects. Three doses of peanut proteins, i.e. 50 mcg, 100 mcg and 250 mcg will be evaluated for the study. Following the confirmation of peanut allergy at screening, subjects will be randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 mcg, 100 mcg and 250 mcg peanut protein or placebo. Treatment will be comprised of daily applications of Viaskin Peanut or placebo patch for 12 months. Each subject will undergo two DBPCFCs: one at screening and one at Month 12. A follow up visit will be performed 2 weeks after completion of treatment and the last DBPCFC.

  Eligibility

Ages Eligible for Study:   6 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    1. 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;
    2. at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months;
    3. 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.
  • Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue.
  • Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within one year prior to the screening visit.
  • Allergy or known history of reaction to Tegaderm®.
  • Subjects suffering from generalized dermatologic diseases (e.g. severe atopic dermatitis, uncontrolled generalized eczema, keratosis pilaris, ichthyosis vulgaris) with no intact skin zones to apply the patches.
  • Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
  • Participation in another clinical intervention study in the three months prior to the screening visit.
  • Subjects on any experimental drugs or treatments.

Other inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675882

Locations
United States, California
University of California, Rady Childrens Hospital
San Diego, California, United States, 92123
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Massachusetts
Boston Childrens' Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
United States, Washington
ASTHMA, Inc.
Seattle, Washington, United States, 98115
Canada, Ontario
Cheema Research Inc.
Mississauga, Ontario, Canada, L5A 3V4
Ottawa Allergy Asthma Research Institute
Ottawa, Ontario, Canada, K1Y 4G2
Gordon Sussman Clinical Research
Toronto, Ontario, Canada, M4V 1R2
Canada, Quebec
Centre de Recherche Appliquée en Asthme et Allergie de Québec
Sainte-Foy, Quebec, Canada, G1V 4M6
France
Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
Bordeaux, France, 33076
Hôpital Saint Vincent de Paul
Lille, France, 59020
GCS des hôpitaux pédiatriques
Nice, France, 06200
Hôpital Necker
Paris, France, 75743
Nouvel Hôpital Civil
Strasbourg, France, 67091
Hôpitaux De Brabois
Vandoeuvre-les-Nancy, France, 54511
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 GD
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Poland
Szpital Uniwersytecki nr2
Bydgoszcz, Poland, 85168
Szpital Kliniczny UM
Łódź, Poland, 92213
Sponsors and Collaborators
DBV Technologies
  More Information

No publications provided

Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT01675882     History of Changes
Other Study ID Numbers: VIPES, 2011-002550-32
Study First Received: August 17, 2012
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Canada: Health Canada
Canada: Ethics Review Committee
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Netherlands: Medicines Evaluation Board (MEB)
Netherlands: Independent Ethics Committee
Poland: Ministry of Health
Poland: Ethics Committee

Keywords provided by DBV Technologies:
Food allergy
Immediate hypersensitivity
Whole peanut extract
Allergenic product
Specific Immunotherapy
Epicutaneous Immunotherapy (EPIT)

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 30, 2014