Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 105
Summary
- Conditions
- Peanut Allergy
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 2:1 randomizationMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Double-BlindedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 3 years
- Gender
- Both males and females
Description
To determine the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut-allergic children aged 1 to < 4 years.
To determine the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut-allergic children aged 1 to < 4 years.
Tracking Information
- NCT #
- NCT03736447
- Collaborators
- Not Provided
- Investigators
- Study Director: Freddy Byrth Aimmune Therapeutics