PALISADE Follow-on Study (ARC004)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

Detailed Description
-----------------
This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Official Title
-----------------
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Biological: AR101


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completion of the ARC003 study Written informed consent and/or assent from subjects/guardians as appropriate Use of effective birth control by sexually active female subjects of child-bearing potential Key Exclusion Criteria: Early discontinuation from the ARC003 study Meets any longitudinally applicable ARC003 study exclusion criteria (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 (Placebo Crossovers)<br>Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC). | Biological: AR101<br>* AR101 powder provided in capsules & sachets<br>|
| Other: Group 2 (Active Rollovers)<br>Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval. | Biological: AR101<br>* AR101 powder provided in capsules & sachets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall). | Up to 126 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years). | Up to 126 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, PALISADE