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 enrollmentPart 2: Male or female aged 4 through 65 years (inclusive) on the day of enrollmentPart 3: Male or female aged 4 through 65 years (inclusive) on the day ofrandomization

• 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 mgchallenge dose of peanut protein on screening DBPCFC Cohorts 9-10: Experiencedose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on thescreening DBPCFC Part 3: Experience dose-limiting symptoms at the 3 mg, 10 mg, 30 mgor 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 scoreof 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 enrollmentSubjects 4 years old with a history of recurrent wheeze requiring inhaledcorticosteroids for 2 consecutive weeks or more within 3 months prior to enrollment

• Up-dosing with any allergy immunotherapy product. Maintenance dose of anysubcutaneous immunotherapy product other than peanut is allowed

• History of peanut oral immunotherapy within the last 12 months prior to visit 1

• Chronic or acute oral inflammation at enrollment

• History of cardiovascular disease, including uncontrolled or inadequately controlledhypertension

• Currently using any prohibited medication on the list of prohibited medication

• Part 1 and 2: Allergic symptoms in reaction to the placebo part of the screeningDBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part ofthe screening DBPCFC

• History of severe or life-threatening episode of anaphylaxis or anaphylactic shockwithin 60 days of the screening DBPCFC

• Part 1 and 2: Asthma according to below criteria:

• Severe asthma as per the current GINA guidelines

• Uncontrolled or poorly controlled asthma as per the current GINA guidelines

• Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroids)

• History of 2 or more systemic corticosteroid courses within 6 months ofscreening

• Prior intubation/mechanical ventilation for asthma

• Emergency room visit or hospitalization for asthma in the 12 months prior toscreening

• Any history of a life-threatening asthma attack

• Part 3: Asthma fulfilling the below criteria:

• History of 2 or more systemic corticosteroid courses within 6 months ofscreening

• Prior intubation/mechanical ventilation for asthma

• Emergency room visit or hospitalization for asthma in the 12 months prior toscreening

• Any history of a life-threatening asthma attack

• (US only) Severe asthma as per the current GINA guidelines

• (US only) Uncontrolled or poorly controlled asthma as per the current GINAguidelines

• (US only) Asthma that requires more than a daily maintenance dose above 800 μgof inhaled budesonide (or clinically comparable inhaled corticosteroids)