Clinical Trial: Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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.
Brief Summary:
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.
Detailed Summary:
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
Sponsor: DBV Technologies
Current Primary Outcome: 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- The correlation between the presence of peanut protein component(s) and response to treatment. [ Time Frame: From baseline to end of treatment (12 months) ]
- 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) ]
- Primary efficacy endpoint in each age stratum. [ Time Frame: From baseline to end of treatment (12 months) ]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) ]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) ]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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]This safety sub-analysis will be performed on the
Original Secondary Outcome: Same as current
Information By: DBV Technologies
Dates:
Date Received: August 17, 2012
Date Started: August 2012
Date Completion:
Last Updated: September 28, 2015
Last Verified: September 2015
