Overview
This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet.
Description
This is a phase I, open-label, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 2 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents and part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children.
Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study.
In part 1, subjects will receive a peanut SLIT-tablet with one of five increasing doses once daily for 2 weeks.
In part 2, subjects will receive a series of increasing doses of the peanut SLIT-tablet, where each dose is taken once daily for 2 weeks. The entry dose for the up dosing regimen will be determined from part 1.
The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10).
Eligibility
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 peanutcontaining 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
