Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * 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
- * 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)
Ages Eligible for Study
4 Years to 65 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No