Recruiting adolescents and adults aged 12 through 65 years into Part 1 of this peanut allergy study. Individuals must have a documented clinical history of an IgE-mediated allergic reaction towards peanut-containing food. Children, adolescents and adults aged 4 through 65 years will be enrolled into Part 2, however, participants enrolled in Part 1 cannot participate in Part 2.
All participants will receive investigational oral treatment (active study drug) in tablet form. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 13 weeks in Part 1 and 49 weeks in Part 2; the number of study visits and phone visits will vary.
The following information is from ClinicalTrials.gov
Last Update Posted: February 25, 2024
This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet.
Condition or Disease:
Intervention/Treatment:Biological: Peanut SLIT-tablet
Ages Eligible for Study:
4 Years and 65 Years (Child)
Sexes Eligible for Study:
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 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
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
Terms and Conditions – ClinicalTrials.gov
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