NCT01987817

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT

Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Aimmune Therapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Detailed description

This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	AR101 powder provided in capsules	Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
BIOLOGICAL	Placebo powder provided in capsules	Study product formulated to contain only inactive ingredients for use as defined in the protocol

Timeline

• Start date: 2014-02-06
• Primary completion: 2015-01-07
• Completion: 2015-01-07
• First posted: 2013-11-19
• Last updated: 2021-11-30
• Results posted: 2021-11-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study