NCT02198664

Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Aimmune Therapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

Detailed description

This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows: * Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001 * Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001 All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA). Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	AR101 - Peanut protein capsule	Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Timeline

• Start date: 2014-08-27
• Primary completion: 2018-01-04
• Completion: 2018-01-04
• First posted: 2014-07-24
• Last updated: 2021-11-09
• Results posted: 2021-11-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study