Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children (OLFUS-VIPES)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
DBV Technologies
ClinicalTrials.gov Identifier:
NCT01955109
First received: September 24, 2013
Last updated: October 4, 2013
Last verified: September 2013
  Purpose

The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are:

  • To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.
  • To evaluate the safety of long-term treatment with Viaskin Peanut.
  • To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut

Resource links provided by NLM:


Further study details as provided by DBV Technologies:

Primary Outcome Measures:
  • Increase in the threshold dose of peanut protein during long-term treatment assessed by double-blind, placebo-controlled food challenges (DBPCFC) [ Time Frame: From baseline in the VIPES study to Month 12 and to Month 24 (end of treatment) in the OLFUS-VIPES study ] [ Designated as safety issue: No ]
    At Month 12 and at Month 24 in the OLFUS-VIPES study and by treatment group, the proportion of subjects with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut protein or with a ≥10-fold increase of the eliciting dose compared to their baseline eliciting dose observed in the VIPES study. Subjects having received placebo in the VIPES study (Treatment Group 1) and subjects having received Viaskin Peanut in the VIPES study (Treatment Group 2) will be analyzed separately.


Secondary Outcome Measures:
  • Proportion of subjects unresponsive (i.e. showing no objective symptoms during DBPCFC) to a cumulative dose of 1,444 mg peanut protein or above at Month 12 and Month 24. [ Time Frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained unresponsiveness (i.e. showing no objective symptoms during DBPCFC after a period of 2 months without treatment) to a cumulative dose of 1,444 mg peanut protein or above. [ Time Frame: Month 26 of the OLFUS-VIPES study ] [ Designated as safety issue: No ]
  • Median cumulative reactive doses of peanut protein at Month 12 and Month 24 by treatment group. [ Time Frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study ] [ Designated as safety issue: No ]
  • Change from baseline in peanut-specific IgE and IgG4 at Month 12 and Month 24 by treatment group. [ Time Frame: From baseline in the VIPES study to Month 12 and to Month 24 (end of treatment) in the OLFUS-VIPES study ] [ Designated as safety issue: No ]
  • Change from baseline in the average wheal diameter during the skin prick testing (undiluted) at Month 6, Month 12, Month 18 and Month 24 by treatment group [ Time Frame: From baseline in the VIPES study to Month 12 and to Month 24 (end of treatment) in the OLFUS-VIPES study ] [ Designated as safety issue: No ]
  • Change in the Quality of Life (the FAQLQ/FAIM) at Month 12 and Month 24 compared to Day 1 for those countries where the questionnaires were available, globally and by treatment group. [ Time Frame: From Day 1 in the OLFUS-VIPES study to Month 12 and Month 24 (end of treatment) ] [ Designated as safety issue: No ]
  • Adverse events (AEs) by system organ class, severity and relatedness to Viaskin Peanut (all subjects and by age strata). [ Time Frame: Throughout the treatment period (24 months) and the 2-month period without treatment ] [ Designated as safety issue: Yes ]
  • Serious AEs (SAEs) by system organ class, severity and relatedness to Viaskin Peanut (all subjects and by age strata). [ Time Frame: Throughout the treatment period (24 months) and the 2-month period without treatment ] [ Designated as safety issue: Yes ]
  • Systemic allergic symptoms and relatedness to Viaskin Peanut (all subjects and by age strata). [ Time Frame: Throughout the treatment period (24 months) and the 2-month period without treatment ] [ Designated as safety issue: Yes ]
  • Severity of AEs or SAEs elicited during the study and the DBPCFCs (all subjects). [ Time Frame: Throughout the treatment period (24 months) and the 2-month period without treatment ] [ Designated as safety issue: Yes ]
  • Physical examinations, vital signs and Peak Expiratory Flow (PEF) results (all subjects) [ Time Frame: At each of the 10 study visits ] [ Designated as safety issue: Yes ]
  • Laboratory data, Spirometry (FEV1) results (all subjects). [ Time Frame: At 5 visits throughout the study ] [ Designated as safety issue: Yes ]
  • Mean cumulative reactive doses of peanut protein at Month 12 and Month 24 by treatment group. [ Time Frame: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Occurrence of reactions triggered by accidental consumption of peanut during the OLFUS-VIPES study. [ Time Frame: Throughout the treatment period (24 months) and the 2-month period without treatment ] [ Designated as safety issue: Yes ]
    Frequency of accidental consumption, conditions around the accidental consumption, estimated quantity consumed at each occurrence, and associated reactions and severity of reactions

  • Occurrence of "risk-taking behaviors" of subjects towards peanut during the OLFUS-VIPES study. [ Time Frame: Throughout the treatment period (24 months) and the 2-month period without treatment ] [ Designated as safety issue: Yes ]
    Frequency of deliberate consumption of peanut, conditions around the consumption, estimated quantity consumed at each occurrence and associated reactions with these consumptions.


Estimated Enrollment: 220
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: August 2016 (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

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 OLFUS-VIPES study is an open-label follow-up study for subjects who previously were randomized and have completed the VIPES efficacy and safety study. Subjects will be offered enrollment in this follow-up study to receive an additional 24 months of Viaskin Peanut treatment followed by a period of 2 months without treatment while maintaining a peanut-free diet.

The trial will be conducted at the same sites as the VIPES study 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.

Subjects entering the OLFUS-VIPES study who had previously received Viaskin Peanut at any of the three doses in the VIPES study will continue at the same dose (i.e. 50 mcg or 100 mcg or 250 mcg of peanut protein). Subjects entering the OLFUS-VIPES study who had previously received placebo in the VIPES study will be re-randomized in a 1:1:1 ratio to receive Viaskin Peanut at one of the three doses of peanut protein. The study will remain blinded for all subjects until the VIPES study is unblinded.Once analyses of the VIPES study have been completed and the optimal clinical dose has been demonstrated, the initial treatment groups will be unblinded. It is planned that all subjects in the OLFUS-VIPES study will be switched to this optimal clinical dose of Viaskin Peanut. From this stage onwards, the study will continue in a full open-label manner at one dose. All subjects completing the OLFUS-VIPES study should receive overall 24 months of active treatment followed by a period of 2 months without treatment for those subjects being assessed for sustained unresponsiveness.

  Eligibility

Ages Eligible for Study:   7 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented DBPCFC at Month 12 in the VIPES study.
  • Signed informed consent from adult subjects or parent(s)/guardian(s) of children <18 years and children's assent for children >7 years or as per country-specific regulations or laws. This consent should be signed no later than Visit 11 in the VIPES study.
  • Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES study.
  • Female subject of childbearing potential 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. Documented sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
  • Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.

Exclusion Criteria:

  • Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine.
  • Pregnancy or lactation.
  • Females of childbearing potential planning a pregnancy in the coming 2 to 3 years.
  • Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore.
  • Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study.
  • 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 with asthma that has evolved and now fulfills any of the criteria 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 receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
  • Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
  • Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study.
  • Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study.
  • Allergy or known history of reaction to Tegaderm®.
  • Subjects suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones to apply the patches.
  • Any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
  • A history of non compliance in the VIPES study. Non compliance is defined as subjects not applying the patch at all for 60 days or more during the whole VIPES study duration
  • Participation in another clinical intervention study in the past year, other than the VIPES study.
  • Subjects on any experimental drugs in the past year, other than those used in the VIPES study.

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: NCT01955109

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
Sponsors and Collaborators
DBV Technologies
  More Information

No publications provided

Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT01955109     History of Changes
Other Study ID Numbers: OLFUS-VIPES
Study First Received: September 24, 2013
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Independent 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:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014