CHU Sainte-Justine
Montreal, Quebec, H3T1C5, Canada
NCT Number: NCT04872218
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.
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Notify Me14 year–50 year
All sexes
Interventional
Phase 2
Montreal, Quebec, H3T1C5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 weeks
Relative change in peanut specific/total IgE from baseline to week 24
Time frame: 24 weeks
Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24
Time frame: 24 weeks
Absolute change in peanut-specific IgG4 from baseline to week 24
Time frame: Assessed between week 36 and week 48
Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated
Time frame: 48 weeks
Mean cumulative function of food dosing allergic reactions
Time frame: 36 weeks
Highest tolerated dose on an oral food challenge at week 36
Time frame: 36 weeks
Time from the onset of oral immunotherapy to the maintenance dose of 300mg
Time frame: 48 weeks
Overall rate of adverse events
Time frame: week 12, week 24 and week 48
Change in peanut atopy patch test from baseline
Time frame: week 12, week 24 and week 48
Change in peanut skin test from baseline
Time frame: weeks 2, 6, 12, 36 and 48
Relative change in peanut specific/total IgE from baseline
Time frame: weeks 2, 6, 12, 36 and 48
Relative change in peanut-specific IgG4/IgE ratio from baseline
Time frame: weeks 2, 6, 12, 36 and 48
Absolute change from baseline in peanut-specific IgG4
Philippe Bégin
Other
A Double-blind Randomized Controlled Trial of 6-month of Abatacept vs Placebo as Adjuvant to Peanut Oral Immunotherapy to Induce Immunologic Changes in Patients With Severe Persistent Peanut Allergy
Acronym: ATARI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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