Clinical trial NCT02198664: Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Official title: Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peanut Allergy
Keywords: Characterized Peanut Allergen
Peanut
OIT
Oral Desensitization
Peanut Allergen
Peanut-Allergic Children
Children
Peanut-Allergic Adults
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-24
Enrollment: 47
Sex: ALL
Minimum age (years): 4
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

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

Key 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

Primary outcomes:
measure: 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
timeFrame: Up to 90 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 36 weeks
measure: 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.
timeFrame: Up to 60 weeks.
measure: Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein
timeFrame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
measure: Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated
timeFrame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
measure: Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance
timeFrame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
measure: Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance
timeFrame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
measure: Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance
timeFrame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
measure: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC
timeFrame: Up to 36 weeks for up-dosing
measure: Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC
timeFrame: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
measure: 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.
timeFrame: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel HIll
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
affiliation: Aimmune Therapeutics
name: Director of Regulatory Affairs
role: STUDY_DIRECTOR
References:
citation: Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.