At a glance
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Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
In Brief
A Phase 2 clinical trial evaluating Peanut Oral Immunotherapy - Liquid Extract, Placebo for Peanut Oral Immunotherapy - Liquid Extract form, and 2 other interventions for Peanut Hypersensitivity. Completed, enrolled 146 participants across 5 sites.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Study Details
Timeline
Interventions
Used during initial dose escalation for doses 0.1 to 0.8 mg.
Similar in appearance, texture, and taste to peanut liquid extract.
This will be used for the remainder of dose escalation, build-up, and maintenance.
Similar in appearance, texture, and taste to peanut flour.