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This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
Full description
This is a phase I/II, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 3 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents; part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children; part 3 will evaluate the efficacy of 2 maintenance doses of the SLIT-tablet primarily in adolescents and children; a small number of adults may also be included.
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 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.
In part 3, subjects will be randomized into 3 treatment groups (UDR and Maintenance A, UDR and Maintenance B, Placebo UDR and Placebo). Subjects will receive a series of increasing doses of the peanut SLIT-tablet , where each dose is taken once daily for 2 weeks, followed by Maintenance A or B once daily for 24 weeks; or the corresponding Placebo.
The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10) and 3 treatment groups in part 3.
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Inclusion and exclusion criteria
KEY INCLUSION CRITERIA:
Subjects are eligible to be included in the trial only if all the following criteria apply:
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 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:
Part 3: Asthma fulfilling the below criteria:
Primary purpose
Allocation
Interventional model
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192 participants in 13 patient groups, including a placebo group
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Central trial contact
Clinical Project Manager
Data sourced from clinicaltrials.gov
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