Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy

KEY INCLUSION CRITERIA: Subjects are eligible to be included in the trial only if all the following criteria apply: * Part 1: Male or female aged 12 through 65 years (inclusive) on the day of enrollment Part 2: Male or female aged 4 through 65 years (inclusive) on the day of enrollment Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization * Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food * Peanut-specific serum IgE ≥ 0.7 kU/L at screening measured at central laboratory * Skin prick test to peanut ≥ 5 mm at screening * Cohorts 1-8: Experience dose-limiting symptoms at the 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening DBPCFC Part 3: Experience dose-limiting symptoms at the 3 mg, 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC KEY EXCLUSION CRITERIA: Subjects are excluded from the trial if any of the following criteria apply: * Diagnosis or history of eosinophilic esophagitis * Uncontrolled asthma as defined by the Asthma Control Test questionnaire with a score of 19 or below at enrollment (subjects with a diagnosis of asthma only) * All subjects ≥ 5 years old with FEV1 or PEFR \< 70% of predicted value at enrollment Subjects 4 years old with a history of recurrent wheeze requiring inhaled corticosteroids for 2 consecuti…