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

Phase 2

Completed

• Conditions: Peanut Allergy
• Interventions: Biological: AR101 - Peanut protein capsule

• Registration Number: NCT02198664
• Lead Sponsor: Aimmune Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Study Start: 2014-08-27
• Primary Completion: 2018-01-04
• Study Completion: 2018-01-04
• Disposition First Submitted: 2019-08-16
• Disposition First Submitted QC: 2019-08-19
• Disposition First Posted: 2019-08-21
• Results First Submitted: 2021-08-04
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-08
• Last Update Submitted: 2021-11-08
• Results First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Completion of ARC001 study
• No change in the status of any longitudinally applicable ARC001 inclusion criteria

Key

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Exclusion Criteria

• Early termination from ARC001
• Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
• A lapse in dosing of more than 10 days from completion of ARC001
• Change in the status of any longitudinally applicable ARC001 exclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARC001 AR101 group	AR101 - Peanut protein capsule	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.
ARC001 placebo group	AR101 - Peanut protein capsule	Subjects who received placebo in study ARC001.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months	Up to 90 weeks	TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).

Secondary Outcome Measures

Name	Time	Method
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC	Up to 36 weeks
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.	Up to 60 weeks.
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein	Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)	The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated	Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)	The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance	Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance	Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance	Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC	Up to 36 weeks for up-dosing	Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC	Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)	Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.	Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)	A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.

Trial Locations

Locations (8)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

UC San Diego; 🇺🇸 San Diego, California, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of North Carolina Chapel HIll; 🇺🇸 Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Medical Center Dallas; 🇺🇸 Dallas, Texas, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States