Clinical trial NCT03292484: Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Official title: A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peanut Allergy
Keywords: AR101
Characterized Peanut Allergen
OIT (oral immunotherapy)
Peanut Allergy
Allergy
Peanut-Allergic Children
Peanut-Allergic Adults
Desensitization
CPNA (Characterized Peanut Allergen)
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 911
Sex: ALL
Minimum age (years): 1
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

Detailed description: This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

Eligibility criteria: Key Inclusion Criteria:

* Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
* Written informed consent and/or assent from subjects/guardians as appropriate
* Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

* Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
* Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study
* Discontinued early from the parent study

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With TEAEs That Led to a Change in Treatment Regimen
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With TEAEs That Led to Early Withdrawal
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With Use of Epinephrine as a Rescue Medication
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
measure: Number of Participants With Eosinophilic Esophagitis (EoE)
timeFrame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Secondary outcomes:
measure: Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
timeFrame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
measure: Maximum Tolerated Challenge Dose at Each Food Challenge
timeFrame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
measure: Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges
timeFrame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy and Asthma Center
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona, Allergy, Asthma & Immunology Associates
state: Arizona
city: Tucson
country: United States
facility: Banner Univ. of Arizona Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Jonathan Corren, M.D., Inc.
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
state: California
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 and Asthma Research LPCH El Camino Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital, Div. of Allergy & Immunology
state: California
city: San Francisco
country: United States
facility: UCSF, Benioff Children's Hospital - Allergy and Immunology
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
city: Walnut Creek
country: United States
facility: Bay Area Allergy
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers, P.C.
state: Colorado
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Largo
country: United States
facility: Sher Allergy Specialists - Center for Cough
state: Florida
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Asthma Allergy & Immunology Clinical Research Unit
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy and 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: The University of Chicago Medicine, Comer Children's Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates
state: Illinois
city: Carmel
country: United States
facility: Riley Children's Specialists
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Pediatric Clinical Research Unit
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
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: Ocean City
country: United States
facility: Atlantic Research Center
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health System
state: New York
city: New York
country: United States
facility: Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: Univ. of Rochester Medical Center, Golisano Children's Hosp.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center
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: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical Research
state: Oklahoma
city: Clackamas
country: United States
facility: Columbia Asthma & Allergy Clinic
state: Oregon
city: Portland
country: United States
facility: Baker Allergy, Asthma and 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: North 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 Bldg.
state: Tennessee
city: Austin
country: United States
facility: 'Specially for Children Allergy, Asthma and Immunology Clinic
state: Texas
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: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: ASTHMA, Inc. Clinical Research Center
state: Washington
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
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
state: Ontario
city: Bordeaux
country: France
facility: Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
state: Cedex
city: Lille
country: France
facility: Hopital Saint Vincent de Paul- Service d'Allergologie
state: Cedex
city: Lille
country: France
facility: Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
state: Cedex
city: Strasbourg
country: France
facility: Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
state: Cedex
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Cork
country: Ireland
facility: Cork University Hospital, UCC Department of Paediatrics and Child Health
city: Dublin
country: Ireland
facility: National Children's Research Centre, Our Lady's Children's Hospital Crumlin
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Province Of Padua
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 General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: H. Infantil Universitario Niño Jesús, Servicio de Alergia
city: Madrid
country: Spain
facility: Madrid Hospital Clinico San Carlos, Servicio de Alergia
city: Stockholm
country: Sweden
facility: Sachsska Children and Youth Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal infirmary
state: Leicestershire
city: Gorleston-on-Sea
country: United Kingdom
facility: James Paget University Hospital
state: Norfolk
city: London
country: United Kingdom
facility: Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
city: London
country: United Kingdom
facility: St Mary's Hospital - Paediatric Research Unit
city: Manchester
country: United Kingdom
facility: Children's Clinical Research Facility, Royal Manchester Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton Foundation NHS Trust
city: Wythenshawe
country: United Kingdom
facility: Central Manchester University Hospitals
Study officials:
affiliation: Director, Clinical Operations
name: Jen Garcia
role: STUDY_CHAIR
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.
citation: Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.