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

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut allergy, Children, Adolescent, Adult Read More

Inclusion criteria apply to both part 1 and part 2 of the trial, unless otherwise specified.

Subjects are eligible to be included in the trial only if all the following criteria apply:

• Part 1: Male or female aged 18 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
• Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food
• Peanut-specific serum IgE ≥ 0.7 kUA/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 double-blind, placebo-controlled food challenge
• Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening double-blind, placebo-controlled food challenge

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)
• Part 1 and 2: All subjects ≥ 5 years old with FEV1 or PEFR < 70% of predicted value at enrollment
• Part 2: Subjects 4 years old with a history of recurrent wheeze requiring inhaled corticosteroids for 2 consecutive weeks or more within 3 months prior to enrollment
• Up-dosing with any allergy immunotherapy product. Maintenance dose of any subcutaneous immunotherapy product other than peanut is allowed
• History of peanut oral immunotherapy within the last 12 months prior to visit 1