This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy. This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission. Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
24 week treatment of IV abatacept following recommended dosages from the monograph
24 week treatment of IV placebo following recommended dosages from the abatacept monograph
Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.
CHU Sainte-Justine
Montreal, Quebec, Canada
Peanut specific/total IgE at week 24
Relative change in peanut specific/total IgE from baseline to week 24
Time frame: 24 weeks
Peanut-specific IgG4/IgE ratio at week 24
Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24
Time frame: 24 weeks
Peanut-specific IgG4 at week 24
Absolute change in peanut-specific IgG4 from baseline to week 24
Time frame: 24 weeks
Sustained tolerance
Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated
Time frame: Assessed between week 36 and week 48
Food dosing reactions
Mean cumulative function of food dosing allergic reactions
Time frame: 48 weeks
Desensitization
Highest tolerated dose on an oral food challenge at week 36
Time frame: 36 weeks
Desensitization speed
Time from the onset of oral immunotherapy to the maintenance dose of 300mg
Time frame: 36 weeks
Adverse events
Overall rate of adverse events
Time frame: 48 weeks
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