A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO STUDY THE VIASKIN(RegisteredTM) PEANUT[Single Quote]S EFFICACY AND SAFETY FOR TREATING PEANUT ALLERGY IN CHILDREN AND ADULTS
This is a 12-month double-blind, placebo-controlled, randomized trial to study the efficacy and safety of Viaskin[RegisteredTM] Peanut, an allergen extract of peanut administered epicutaneously using the Viaskin[RegisteredTM] epicutaneous delivery system in subjects from 6 to 55 years old with a history of immediate hypersensitive reaction to peanut protein. The trial will be conducted at approximately 22-24 sites with investigators and staff trained and experienced in the diagnosis and the management of peanut allergy and anaphlaxis, and who are capable of performing a double-blind
placebo-controlled peanut food challenge in adult and/or pediatric subjects. Three doses of peanut proteins, i.e. 50 [MiCRo-SYMBoL]g, 100 [MiCRo-SYMBoL]g and 250 [MiCRo-SYMBoL]g per patch will be evaluated in the study.
Following the confirmation of peanut allergy at screening with a dose-escalating DBPCFC, subjects will be
randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 [MiCRo-SYMBoL]g, 100 [MiCRo-SYMBoL]g and 250 [MiCRo-SYMBoL]g
peanut proteins or placebo.
Treatment will be comprised of daily applications of Viaskin Peanut or placebo patch for 12 months. each subject will undergo four DBPCFCs:
one at screening and one at 11 months at the end of the treatment period.
amendment: For those not choosing to roll over into the Follow on oLFuS study, Visit 12 will be the last study visit. For those choosing to roll over to the follow on study, Visit 11 will be their last ViPeS study visit.
Doses of peanut proteins will be
given during the challenge every 30 min starting with a start dose of 1 mg peanut proteins and proceeding
up to a highest dose of 2,000 mg of peanut proteins for the challenge conducted at the end of treatment.
in total, during this study, subjects will be required to attend 12 study visits.
in addition to DBPCFC assessments, subjects will undergo other efficacy parameter assessments at months
3, 6 and 12 including skin prick tests (SPTs), titrated SPTs, determination of the changes in immunological
markers and basophil activation tests. Key assessments of safety, will be performed at each study visit by
the investigators including spirometry, Peak Flow measurements, vital signs, physical examinations, clinical
lab assessments. in between visits, subjects will report safety data on the diary cards.
a follow-up visit will be performed 2 weeks after completion of treatment and after the last DBPCFC.
Repeated daily application of Viaskin with a duration of application of 24 hours will be made on the outer
part of both arms for adults (18-55 years) and adolescents (12-17 years) and on the inter-scapular area of
the back for children (6-11 years). However, the duration of application of the Viaskin will be progressively
increased for the first 3 weeks of treatment as follows: The Viaskin will be applied daily for a duration of 3
hours during the first week; then the duration of application will be extended to 6 hours per day during the
second week; then the duration of application will be extended to 12 hours per day during the third week.
From the 22nd day of treatment onwards (the beginning of the fourth week), the duration of application will
be an entire 24 hours for each Viaskin applied daily until Month 12.
For adults and adolescents, both arms will be used for applying the Viaskins. The specific place where one
Viaskin is administered will represent a [Quote]Zone[Quote]. in total, six zones will be used in each subject to apply the
Viaskins. The first Viaskin will be applied on zone 1, the second Viaskin on zone 2 (after removal of
Viaskin 1), etc, until all six zones have been used, and the dosing will continue with zone 1, zone 2 etc.
in adults and adolescents, zones 1, 2, and 3 are on one arm, while zones 4, 5 and 6 are on the other arm.
in children, zones 1, 2, and 3 are on one side of the spine in the inter-scapular area, while zones 4, 5 and 6
are on the other side of the spine.
Subjects MUST satisfy all of the following entry criteria:
1. 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 peanutfree
2. Peanut-specific IgE level (Phadia CAP-system) > 0.7 kU/L AND a positive peanut SPT with a
largest wheal diameter >= 8 mm.
3. Positive DBPCFC at <= 300 mg of peanut proteins: the eliciting 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.
4. 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.
5. Ability to perform spirometry maneuvers in accordance with the American Thoracic Society
(ATS) guidelines (2005) for subjects of 9 years of age and above. * For those subjects below 9 years of age who cannot perform spirometry, PEF will be considered instead.
6. Subjects and/or parents/guardians willing to comply with all study requirements during their
participation in the study.
7. Signed informed consent from adult subjects or parent(s)/guardian(s) of children < 18 years +
children[Single Quote]s assent (for children > 7 years or as per country specific regulations).