Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      Peanut allergy is a common allergy in the United States, with a prevalence in the general
      population as high as 1%. 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.

      According to the current amended study protocol, all subjects enrolling into the OLFUS-VIPES
      study after having completed the VIPES study will receive the highest dose of Viaskin Peanut,
      i.e. 250 mcg peanut protein, regardless of prior treatment (placebo, 50 mcg, 100 mcg or 250
      mcg Viaskin Peanut) they were receiving in the VIPES study. Subjects who already enrolled
      into the OLFUS-VIPES study under the initial protocol design will all switch to receive the
      250 mcg dose at Month 6 or at Month 12 of treatment in the OLFUS-VIPES study upon approval of
      the amended protocol at their sites. The study will remain blinded for all subjects until the
      VIPES study is unblinded. 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.
    

Intervention name(s): Viaskin Peanut 250 mcg
Intervention type(s): Biological
Intervention description(s): Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT)