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PALISADE Follow-on Study (ARC004)

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AR101
Sponsored by
Aimmune Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, PALISADE

Eligibility Criteria

4 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner University of Arizona Medical Center
  • Arkansas Children's Hospital
  • Allergy & Asthma Associates of Southern California
  • Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
  • Peninsula Research Associates, Inc.
  • Allergy & Asthma Medical Group and Research Center, APC
  • Rady Children's Hospital, San Diego
  • University of California, San Francisco
  • UCLA Medical Center, Santa Monica
  • Children's Hospital Colorado
  • Colorado Allergy & Asthma Centers, P.C.
  • National Jewish Health
  • Children's National Medical Center
  • Sarasota Clinical Research
  • University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
  • Atlanta Allergy & Asthma Clinic, PA
  • Idaho Allergy and Research, dba Idaho Research
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Comer Children's Hospital
  • Sneeze, Wheeze, & Itch Associates, LLC
  • IU North Riley Children's Specialist
  • Chesapeake Clinical Research, Inc.
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Boston Children's Hospital, Div. of Allergy & Immunology
  • Michigan Medicine, Michigan Clinical Research Unit
  • Clinical Research Institute, Inc.
  • Children's Mercy on Broadway
  • Nebraska Medical Research Institute Inc.
  • Atlantic Research Center, LLC
  • Icahn School of Medicine at Mount Sinai, Clinical Research Unit
  • University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
  • Clinical Research of Charlotte
  • Cincinnati Children's Hospital Medical Center
  • Baker Allergy, Asthma & Dermatology
  • The Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of UPMC
  • National Allergy and Asthma Research, LLC
  • Le Bonheur Children's Hospital - Outpatient Building
  • 'Specially for Children Allergy, Asthma and Immunology Clinic
  • Children's Health
  • Western Sky Medical Research
  • Texas Children's Hospital, Baylor College of Medicine
  • Central Texas Health Research
  • Sylvana Research Associates
  • Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
  • Asthma Inc Clinical Research Center
  • Triple A Lab
  • Cheema Research Inc.
  • Ottawa Allergy Research Corp
  • Gordon Sussman Clinical Research, Inc.
  • Montreal Children's Hospital
  • Charité Universitaetsmedizin Berlin
  • University of Frankfurt
  • Cork University Hospital
  • Azienda Ospedaliera di Padova
  • Beatrix Children's Hospital, University Medical Center Groningen
  • University Medical Center Groningen
  • Hospital Gregorio Marañón
  • H. Infantil Universitario Niño Jesús
  • Hospital Clinico San Carlos
  • Sachsska Children and Youth Hospital
  • Guy & St Thomas' NHS foundation Trust
  • Central Manchester University Hospitals, NHS Foundation Trust
  • Central Manchester University Hospitals, NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1 (Placebo Crossovers)

Group 2 (Active Rollovers)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
December 8, 2016
Last Updated
March 16, 2022
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02993107
Brief Title
PALISADE Follow-on Study (ARC004)
Official Title
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aimmune Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, PALISADE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Placebo Crossovers)
Arm Type
Other
Arm Description
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).
Arm Title
Group 2 (Active Rollovers)
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
AR101
Intervention Description
AR101 powder provided in capsules & sachets
Primary Outcome Measure Information:
Title
Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Description
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).
Time Frame
Up to 126 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
Description
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).
Time Frame
Up to 126 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Regulatory Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Banner University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Peninsula Research Associates, Inc.
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center, APC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rady Children's Hospital, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UCLA Medical Center, Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Allergy & Asthma Centers, P.C.
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic, PA
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Idaho Allergy and Research, dba Idaho Research
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
IU North Riley Children's Specialist
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital, Div. of Allergy & Immunology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan Medicine, Michigan Clinical Research Unit
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Children's Mercy on Broadway
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Nebraska Medical Research Institute Inc.
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Atlantic Research Center, LLC
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Clinical Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Baker Allergy, Asthma & Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
National Allergy and Asthma Research, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Le Bonheur Children's Hospital - Outpatient Building
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
'Specially for Children Allergy, Asthma and Immunology Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Texas Children's Hospital, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Asthma Inc Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Triple A Lab
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
Cheema Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Ottawa Allergy Research Corp
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Gordon Sussman Clinical Research, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University of Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12 DC4A
Country
Ireland
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Beatrix Children's Hospital, University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H. Infantil Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Sachsska Children and Youth Hospital
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Guy & St Thomas' NHS foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Central Manchester University Hospitals, NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Central Manchester University Hospitals, NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34389504
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.
Results Reference
derived

Learn more about this trial

PALISADE Follow-on Study (ARC004)

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