MILES Study
A Double-Blind, Placebo-Controlled Randomized Trial to Study the Viaskin® Milk Efficacy and Safety For Treating IgE-Mediated Cow’s Milk Allergy In Children
Clinical Phase 1/2 trail which evaluates the safety and efficacy of Viaskin® Milk epicutaneous immunotherapy (EPIT) treatment, for desensitizing cow’s milk-allergic children. Subjects randomized to placebo or 150 μg, 300 μg, or 500 μg for the first 12 months. After the first year, all subjects received active Viaskin Milk Patch (500 μg). All subjects switched to 300 μg patch late 2018.
PEOPLE Study
Open-Label Follow-Up Study of The PEPITES Study to Evaluate The Long-Term Efficacy And Safety Of The Viaskin® Peanut
Clinical Phase 3 trial. Peanut “Patch” Study. Open label follow-up study to Pepites Study (placebo vs peanut patch for first year). Assess the efficacy and safety of Viaskin® Peanut to induce desensitization to peanut in peanut-allergic subjects 4 -11 years of age
REALISE Study
Long-term Assessment of Safety and Therapeutic Benefit of Viaskin® Peanut Epicutaneous Treatment in Peanut-Allergic Children: A 6-Month Randomized, Double-Blind, Placebo-Controlled Phase III Study Followed by and Open Label Active Treatment
Clinical Phase 3 trial assessing the safety of Viaskin® Peanut to induce desensitization to peanut in peanut-allergic subjects 4 -11 years of age. Subjects randomized to placebo or patch first year, then everyone on 250 μg patch. Subjects who complete the Realise study may continue receiving the study patch through an early access program.
ARC008 Study
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization In Children And Adults (the PALISADE Study)-ARC008 (follow up to ARC004 and ARC003)
Clinical Phase 3 trial evaluating open label peanut oral immunotherapy (OIT). Continuation of ARC003 and ARC004. Initially randomized to Peanut vs Placebo, then open label at a maintenance of 300 mg daily. Demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut. Currently FDA approved as Palforzia.