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:

1. 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
2. Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food
3. Peanut-specific serum IgE ≥ 0.7 kU/L at screening measured at central laboratory
4. Skin prick test to peanut ≥ 5 mm at screening
5. 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:

1. Diagnosis or history of eosinophilic esophagitis
2. 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)
3. 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 consecutive weeks or more within 3 months prior to enrollment
4. Up-dosing with any allergy immunotherapy product. Maintenance dose of any subcutaneous immunotherapy product other than peanut is allowed
5. History of peanut oral immunotherapy within the last 12 months prior to visit 1
6. Chronic or acute oral inflammation at enrollment
7. History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
8. Currently using any prohibited medication on the list of prohibited medication
9. Part 1 and 2: Allergic symptoms in reaction to the placebo part of the screening DBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part of the screening DBPCFC
10. History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC
11. Part 1 and 2: Asthma according to below criteria:

1. Severe asthma as per the current GINA guidelines
2. Uncontrolled or poorly controlled asthma as per the current GINA guidelines
3. Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroids)
4. History of 2 or more systemic corticosteroid courses within 6 months of screening
5. Prior intubation/mechanical ventilation for asthma
6. Emergency room visit or hospitalization for asthma in the 12 months prior to screening
7. Any history of a life-threatening asthma attack
8. Part 3: Asthma fulfilling the below criteria:

1. History of 2 or more systemic corticosteroid courses within 6 months of screening
2. Prior intubation/mechanical ventilation for asthma
3. Emergency room visit or hospitalization for asthma in the 12 months prior to screening
4. Any history of a life-threatening asthma attack
5. (US only) Severe asthma as per the current GINA guidelines
6. (US only) Uncontrolled or poorly controlled asthma as per the current GINA guidelines
7. (US only) Asthma that requires more than a daily maintenance dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroids)