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

Peanut Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292484
• Other study ID #: ARC008
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2017
• Est. completion date: April 27, 2023

Study information

• Verified date: November 2023
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101
AR101

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario
Canada	Triple A Lab	Hamilton	Ontario
Canada	Cheema Research Inc.	Mississauga	Ontario
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Gordon Sussman Clinical Research	Toronto	Ontario
France	Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants	Bordeaux	Cedex
France	Hopital Saint Vincent de Paul- Service d'Allergologie	Lille	Cedex
France	Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center	Lille	Cedex
France	Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg	Strasbourg	Cedex
Germany	Charité Universitaetsmedizin Berlin	Berlin
Germany	University of Frankfurt	Frankfurt
Ireland	Cork University Hospital, UCC Department of Paediatrics and Child Health	Cork
Ireland	National Children's Research Centre, Our Lady's Children's Hospital Crumlin	Dublin
Italy	Azienda Ospedaliera di Padova	Padova	Province Of Padua
Netherlands	Beatrix Children's Hospital, University Medical Center Groningen	Groningen
Netherlands	University Medical Center Groningen	Groningen
Spain	H. Infantil Universitario Niño Jesús, Servicio de Alergia	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Madrid Hospital Clinico San Carlos, Servicio de Alergia	Madrid
Sweden	Sachsska Children and Youth Hospital	Stockholm
United Kingdom	James Paget University Hospital	Gorleston-on-Sea	Norfolk
United Kingdom	Leicester Royal infirmary	Leicester	Leicestershire
United Kingdom	Guy & St Thomas' NHS Foundation Trust, Children Allergies Department	London
United Kingdom	St Mary's Hospital - Paediatric Research Unit	London
United Kingdom	Children's Clinical Research Facility, Royal Manchester Children's Hospital	Manchester
United Kingdom	Sheffield Children's Hospital	Sheffield
United Kingdom	University Hospitals Southampton Foundation NHS Trust	Southampton
United Kingdom	Central Manchester University Hospitals	Wythenshawe
United States	Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	'Specially for Children Allergy, Asthma and Immunology Clinic	Austin	Texas
United States	Specially for Children Allergy, Asthma and Immunology Clinic	Austin	Texas
United States	Chesapeake Clinical Research, Inc.	Baltimore	Maryland
United States	Johns Hopkins Hospital, Pediatric Clinical Research Unit	Baltimore	Maryland
United States	Alabama Allergy and Asthma Center	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Riley Children's Specialists	Carmel	Indiana
United States	University of North Carolina at Chapel Hill, Clinical & Translational Research Center	Chapel Hill	North Carolina
United States	Clinical Research of Charlotte	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	The University of Chicago Medicine, Comer Children's Hospital	Chicago	Illinois
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Columbia Asthma & Allergy Clinic	Clackamas	Oregon
United States	Asthma & Allergy Associates	Colorado Springs	Colorado
United States	Children's Health	Dallas	Texas
United States	Colorado Allergy & Asthma Centers, P.C.	Denver	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Idaho Allergy and Research	Eagle	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Northwell Health System	Great Neck	New York
United States	Texas Children's Hospital, Baylor College of Medicine	Houston	Texas
United States	Children's Mercy on Broadway	Kansas City	Missouri
United States	Sher Allergy Specialists - Center for Cough	Largo	Florida
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy	Los Angeles	California
United States	Jonathan Corren, M.D., Inc.	Los Angeles	California
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	Atlanta Allergy & Asthma Clinic	Marietta	Georgia
United States	Le Bonheur Children's Hospital, Outpatient Bldg.	Memphis	Tennessee
United States	Allergy & Asthma Associates of Southern California	Mission Viejo	California
United States	Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital	Mountain View	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai	New York	New York
United States	Sneeze, Wheeze, & Itch Associates	Normal	Illinois
United States	National Allergy and Asthma Research, LLC	North Charleston	South Carolina
United States	Allergy Associates of the Palm Beaches	North Palm Beach	Florida
United States	Atlantic Research Center	Ocean City	New Jersey
United States	Oklahoma Institute of Allergy and Asthma Clinical Research	Oklahoma City	Oklahoma
United States	Stanford University	Palo Alto	California
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Clinical Research Institute Inc.	Plymouth	Minnesota
United States	Baker Allergy, Asthma and Dermatology	Portland	Oregon
United States	Univ. of Rochester Medical Center, Golisano Children's Hosp.	Rochester	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Allergy & Asthma Medical Group and Research Center	San Diego	California
United States	Rady Children's Hospital, Div. of Allergy & Immunology	San Diego	California
United States	UCSF, Benioff Children's Hospital - Allergy and Immunology	San Francisco	California
United States	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California
United States	UCLA Medical Center, Santa Monica	Santa Monica	California
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Medical Research of Arizona, Allergy, Asthma & Immunology Associates	Scottsdale	Arizona
United States	ASTHMA, Inc. Clinical Research Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	University of South Florida, Asthma Allergy & Immunology Clinical Research Unit	Tampa	Florida
United States	Banner Univ. of Arizona Medical Center	Tucson	Arizona
United States	Bay Area Allergy	Walnut Creek	California
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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