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
    • Charité 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 Marañón
  • 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: AR101; Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 milligrams (mg) per day until discontinuation criteria was met (maximum exposure: 4.8 years).	Biological: AR101; AR101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An AE was any untoward medical occurrence in humans, whether or not considered related to the investigational product (IP), that occurred during the conduct of a clinical study. A SAE was any event that resulted in any of the following: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital abnormality or birth defect, or important medical event that did not result in one of the above outcomes, but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed above. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs	An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs	An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Gastrointestinal (GI) AEs, typically chronic/recurrent GI AEs, that resulted in prolonged interruption of dosing are reported.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs That Led to a Change in Treatment Regimen	An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Number of participants with TEAEs requiring dose interruption and dose reduction of study treatment are reported.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs That Led to Early Withdrawal	An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction	Anaphylaxis was defined by a number of signs and symptoms that occurred alone or in combination within minutes up to a few hours after exposure to a provoking agent. Treatment-emergent anaphylactic reactions included anaphylactic reactions that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding anaphylactic reactions that occurred during or related to a food challenge.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Use of Epinephrine as a Rescue Medication	Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes	An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food challenge.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods	An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food challenge.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Eosinophilic Esophagitis (EoE)	EoE was diagnosed by biopsy/endoscopy.	From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)	During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.	OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Maximum Tolerated Challenge Dose at Each Food Challenge	The maximum tolerated challenge dose for a food challenge was defined as the maximum single dose of peanut protein resulting in no more than mild symptoms and assessed by the investigator to have been tolerated (i.e., the participant did not experience any dose-limiting symptoms). During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.	OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges	Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice. During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.	OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)

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): November 2, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

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: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Food Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: ARC008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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