Clinical trial NCT02993107: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 388
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
timeFrame: Up to 126 weeks
Secondary outcomes:
measure: Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
timeFrame: Up to 126 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Mountain View
country: United States
facility: Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, APC
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Centennial
country: United States
facility: Colorado Allergy & Asthma Centers, P.C.
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
state: Florida
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy and Research, dba Idaho Research
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC
state: Illinois
city: Carmel
country: United States
facility: IU North Riley Children's Specialist
state: Indiana
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital, Div. of Allergy & Immunology
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine, Michigan Clinical Research Unit
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy on Broadway
state: Missouri
city: Bellevue
country: United States
facility: Nebraska Medical Research Institute Inc.
state: Nebraska
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai, Clinical Research Unit
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Research of Charlotte
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Baker Allergy, Asthma & Dermatology
state: Oregon
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital - Outpatient Building
state: Tennessee
city: Austin
country: United States
facility: 'Specially for Children Allergy, Asthma and Immunology Clinic
state: Texas
city: Dallas
country: United States
facility: Children's Health
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor College of Medicine
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Seattle
country: United States
facility: Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Asthma Inc Clinical Research Center
state: Washington
city: Hamilton
country: Canada
facility: Triple A Lab
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research, Inc.
state: Ontario
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Frankfurt am Main
country: Germany
facility: University of Frankfurt
city: Cork
country: Ireland
facility: Cork University Hospital
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Groningen
country: Netherlands
facility: Beatrix Children's Hospital, University Medical Center Groningen
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: H. Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Stockholm
country: Sweden
facility: Sachsska Children and Youth Hospital
city: London
country: United Kingdom
facility: Guy & St Thomas' NHS foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals, NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals, NHS Foundation Trust
Study officials:
affiliation: Aimmune Regulatory Affairs
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.