Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

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

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Biological: AR101

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.

• Study Type: Interventional
• Enrollment (Actual): 911
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Medical Center
    • Hamilton, Ontario, Canada, L8S 1G5
      • Triple A Lab
    • Mississauga, Ontario, Canada, L5A 3V4
      • Cheema Research Inc.
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Research Corp
    • Toronto, Ontario, Canada, M4V 1R2
      • Gordon Sussman Clinical Research
• France
  • Cedex
    • Bordeaux, Cedex, France, 33076
      • Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
    • Lille, Cedex, France, 59020
      • Hopital Saint Vincent de Paul- Service d'Allergologie
    • Lille, Cedex, France, 59037
      • Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
    • Strasbourg, Cedex, France, 67091
      • Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin
  • Frankfurt, Germany, 60590
    • University of Frankfurt
• Ireland
  • Cork, Ireland, T12 DC4A
    • Cork University Hospital, UCC Department of Paediatrics and Child Health
  • Dublin, Ireland, D12 V004
    • National Children's Research Centre, Our Lady's Children's Hospital Crumlin
• Italy
  • Province Of Padua
    • Padova, Province Of Padua, Italy, 35128
      • Azienda Ospedaliera di Padova
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Groningen, Netherlands, 9700 RB
    • Beatrix Children's Hospital, University Medical Center Groningen
• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28009
    • H. Infantil Universitario Niño Jesús, Servicio de Alergia
  • Madrid, Spain, 28040
    • Madrid Hospital Clinico San Carlos, Servicio de Alergia
• Sweden
  • Stockholm, Sweden, 118 83
    • Sachsska Children and Youth Hospital
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
  • London, United Kingdom, W2 1NY
    • St Mary's Hospital - Paediatric Research Unit
  • Manchester, United Kingdom, M13 9WL
    • Children's Clinical Research Facility, Royal Manchester Children's Hospital
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's Hospital
  • Southampton, United Kingdom, SO16 6YD
    • University Hospitals Southampton Foundation NHS Trust
  • Wythenshawe, United Kingdom, M23 9LT
    • Central Manchester University Hospitals
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Leicester Royal Infirmary
  • Norfolk
    • Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA
      • James Paget University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Allergy and Asthma Center
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Medical Research of Arizona, Allergy, Asthma & Immunology Associates
    • Tucson, Arizona, United States, 85724
      • Banner Univ. of Arizona Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90025
      • Jonathan Corren, M.D., Inc.
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California
    • Mountain View, California, United States, 94040
      • Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
    • Palo Alto, California, United States, 94305
      • Stanford University
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital, Div. of Allergy & Immunology
    • San Francisco, California, United States, 95148
      • UCSF, Benioff Children's Hospital - Allergy and Immunology
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Valley Research Center
    • Santa Monica, California, United States, 90404
      • UCLA Medical Center, Santa Monica
    • Walnut Creek, California, United States, 94598
      • Bay Area Allergy
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma & Allergy Associates
    • Denver, Colorado, United States, 80206
      • National Jewish Health
    • Denver, Colorado, United States, 80230
      • Colorado Allergy & Asthma Centers, P.C.
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Health System
  • Florida
    • Largo, Florida, United States, 33778
      • Sher Allergy Specialists - Center for Cough
    • North Palm Beach, Florida, United States, 33408
      • Allergy Associates of the Palm Beaches
    • Sarasota, Florida, United States, 34239
      • Sarasota Clinical Research
    • Tampa, Florida, United States, 33613
      • University of South Florida, Asthma Allergy & Immunology Clinical Research Unit
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
    • Marietta, Georgia, United States, 30060
      • Atlanta Allergy & Asthma Clinic
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Idaho Allergy and Research
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine, Comer Children's Hospital
    • Chicago, Illinois, United States, 60611-2605
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Riley Children's Specialists
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy & Asthma Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Chesapeake Clinical Research, Inc.
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital, Pediatric Clinical Research Unit
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute Inc.
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Children's Mercy on Broadway
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health System
    • New York, New York, United States, 10029
      • Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
    • Rochester, New York, United States, 14642
      • Univ. of Rochester Medical Center, Golisano Children's Hosp.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, Clinical & Translational Research Center
    • Charlotte, North Carolina, United States, 28277
      • Clinical Research of Charlotte
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73131
      • Oklahoma Institute of Allergy and Asthma Clinical Research
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Columbia Asthma & Allergy Clinic
    • Portland, Oregon, United States, 97223
      • Baker Allergy, Asthma and Dermatology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Le Bonheur Children's Hospital, Outpatient Bldg.
  • Texas
    • Austin, Texas, United States, 78723
      • Specially for Children Allergy, Asthma and Immunology Clinic
    • Austin, Texas, United States, 78723
      • 'Specially for Children Allergy, Asthma and Immunology Clinic
    • Dallas, Texas, United States, 75235
      • Children's Health
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital, Baylor College of Medicine
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98115-2024
      • ASTHMA, Inc. Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Pathway 1, 2, 3, 4, 5; Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule).	Biological: AR101; AR101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events including serious adverse events (Safety and Tolerability)	To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101	Approximately 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peanut allergy desensitization through extended maintenance dosing of AR101	Proportion of subjects who have completed 3-5 years of AR101 (depending on age group) who tolerate each food challenge dose double-blind, placebo-controlled food challenge (DBPCFC) to a maximum 2000mg peanut protein	Following 3-5 years of AR101 treatment

Collaborators and Investigators

• Sponsor: Aimmune Therapeutics, Inc.
• Investigators: Study Chair: Jen Garcia, Director, Clinical Operations

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Click to request more information about this study.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Allergy; Peanut Allergy; AR101; Peanut-Allergic Children; Desensitization; OIT (oral immunotherapy); Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); Peanut-Allergic Adults
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: ARC008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No