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

Completed · Phase 2

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID: NCT01955109
Run by: DBV Technologies
People needed: 171
Starts: 2013-09-01
Expected to finish: 2016-09-01
Last updated by the study team: 2022-06-30

Who can join

Age: 7 and older, up to 56. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 year.
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® with no possibilities to use an alternative dressing approved by the sponsor.
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 (this can be either consecutive or intermittent non-application of the patches) 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.

Where it is running

University of California, Rady Childrens Hospital — San Diego, California, United States
Stanford University School of Medicine — Stanford, California, United States
Children's Memorial Hospital — Chicago, Illinois, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Boston Childrens' Hospital — Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
Children's Medical Center Dallas — Dallas, Texas, United States
ASTHMA, Inc. — Seattle, Washington, United States
Cheema Research Inc. — Mississauga, Ontario, Canada
Ottawa Allergy Asthma Research Institute — Ottawa, Ontario, Canada
Gordon Sussman Clinical Research — Toronto, Ontario, Canada
Centre de Recherche Appliquée en Asthme et Allergie de Québec — Sainte-Foy, Quebec, Canada
Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin — Bordeaux, France
Hôpital Saint Vincent de Paul — Lille, France
GCS des hôpitaux pédiatriques — Nice, France
Hôpital Necker — Paris, France
Nouvel Hôpital Civil — Strasbourg, France
Hôpitaux De Brabois — Vandœuvre-lès-Nancy, France
Erasmus MC — Rotterdam, Netherlands
UMC Utrecht — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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