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

Open to people ages 4-65

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

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 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
• Chronic or acute oral inflammation at enrollment
• History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• 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 screening

  DBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part of the screening DBPCFC

• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 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 of screening
  • Prior intubation/mechanical ventilation for asthma
  • Emergency room visit or hospitalization for asthma in the 12 months prior to screening
  • 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 of screening
  • Prior intubation/mechanical ventilation for asthma
  • Emergency room visit or hospitalization for asthma in the 12 months prior to screening
  • 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 GINA guidelines
  • (US only) Asthma that requires more than a daily maintenance dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroids)