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

NCT03292484 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARC008
• Study Type: interventional
• Target: 911
• Locations: 10 countries
• Sites: 93

Brief Summary

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

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)

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)

  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

  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

  OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)

Study Arms (1)

AR101

EXPERIMENTAL

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

Interventions

AR101 BIOLOGICAL

AR101

AR101

Eligibility Criteria

• Age: 1 Year - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (93)

Alabama Allergy and Asthma Center

Birmingham, Alabama, 35209, United States

Location

Medical Research of Arizona, Allergy, Asthma & Immunology Associates

Scottsdale, Arizona, 85251, United States

Location

Banner Univ. of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Jonathan Corren, M.D., Inc.

Los Angeles, California, 90025, United States

Location

Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy

Los Angeles, California, 90027, United States

Location

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital

Mountain View, California, 94040, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Rady Children's Hospital, Div. of Allergy & Immunology

San Diego, California, 92123, United States

Location

UCSF, Benioff Children's Hospital - Allergy and Immunology

San Francisco, California, 95148, United States

Location

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

Bay Area Allergy

Walnut Creek, California, 94598, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Asthma & Allergy Associates

Colorado Springs, Colorado, 80907, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Colorado Allergy & Asthma Centers, P.C.

Denver, Colorado, 80230, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Sher Allergy Specialists - Center for Cough

Largo, Florida, 33778, United States

Location

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

Sarasota Clinical Research

Sarasota, Florida, 34239, United States

Location

University of South Florida, Asthma Allergy & Immunology Clinical Research Unit

Tampa, Florida, 33613, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Atlanta Allergy & Asthma Clinic

Marietta, Georgia, 30060, United States

Location

Idaho Allergy and Research

Eagle, Idaho, 83616, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2605, United States

Location

The University of Chicago Medicine, Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Sneeze, Wheeze, & Itch Associates

Normal, Illinois, 61761, United States

Location

Riley Children's Specialists

Carmel, Indiana, 46032, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47713, United States

Location

Family Allergy & Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

Chesapeake Clinical Research, Inc.

Baltimore, Maryland, 21236, United States

Location

Johns Hopkins Hospital, Pediatric Clinical Research Unit

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology

Ann Arbor, Michigan, 48106, United States

Location

Clinical Research Institute Inc.

Plymouth, Minnesota, 55441, United States

Location

Children's Mercy on Broadway

Kansas City, Missouri, 64111, United States

Location

Atlantic Research Center

Ocean City, New Jersey, 07712, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Northwell Health System

Great Neck, New York, 11021, United States

Location

Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Univ. of Rochester Medical Center, Golisano Children's Hosp.

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill, Clinical & Translational Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Clinical Research of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45231, United States

Location

Oklahoma Institute of Allergy and Asthma Clinical Research

Oklahoma City, Oklahoma, 73131, United States

Location

Columbia Asthma & Allergy Clinic

Clackamas, Oregon, 97015, United States

Location

Baker Allergy, Asthma and Dermatology

Portland, Oregon, 97223, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420, United States

Location

Le Bonheur Children's Hospital, Outpatient Bldg.

Memphis, Tennessee, 38105, United States

Location

'Specially for Children Allergy, Asthma and Immunology Clinic

Austin, Texas, 78723, United States

Location

Specially for Children Allergy, Asthma and Immunology Clinic

Austin, Texas, 78723, United States

Location

Children's Health

Dallas, Texas, 75235, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

ASTHMA, Inc. Clinical Research Center

Seattle, Washington, 98115-2024, United States

Location

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Triple A Lab

Hamilton, Ontario, L8S 1G5, Canada

Location

Cheema Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Ottawa Allergy Research Corp

Ottawa, Ontario, K1G 6C6, Canada

Location

Gordon Sussman Clinical Research

Toronto, Ontario, M4V 1R2, Canada

Location

Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants

Bordeaux, Cedex, 33076, France

Location

Hopital Saint Vincent de Paul- Service d'Allergologie

Lille, Cedex, 59020, France

Location

Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center

Lille, Cedex, 59037, France

Location

Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

Strasbourg, Cedex, 67091, France

Location

Charité Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

University of Frankfurt

Frankfurt, 60590, Germany

Location

Cork University Hospital, UCC Department of Paediatrics and Child Health

Cork, T12 DC4A, Ireland

Location

National Children's Research Centre, Our Lady's Children's Hospital Crumlin

Dublin, D12 V004, Ireland

Location

Azienda Ospedaliera di Padova

Padua, Province Of Padua, 35128, Italy

Location

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

H. Infantil Universitario Niño Jesús, Servicio de Alergia

Madrid, 28009, Spain

Location

Madrid Hospital Clinico San Carlos, Servicio de Alergia

Madrid, 28040, Spain

Location

Sachsska Children and Youth Hospital

Stockholm, 118 83, Sweden

Location

Leicester Royal infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

James Paget University Hospital

Gorleston-on-Sea, Norfolk, NR31 6LA, United Kingdom

Location

Guy & St Thomas' NHS Foundation Trust, Children Allergies Department

London, SE1 7EH, United Kingdom

Location

St Mary's Hospital - Paediatric Research Unit

London, W2 1NY, United Kingdom

Location

Children's Clinical Research Facility, Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

University Hospitals Southampton Foundation NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

Central Manchester University Hospitals

Wythenshawe, M23 9LT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34389504 DERIVED

• 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.

  PMID: 34320250 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Results Point of Contact

• Title: Jay Patel
• Organization: Aimmune Therapeutics, a Nestlé Health Science Company

jay.patel@uk.nestle.com

(800) 422-2752

Study Officials

• Jen Garcia

  Director, Clinical Operations

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: November 2, 2017
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); SE (1); IT (1); US (65); IE (2); ES (3); CA (5); FR (4); NL (2); GB (8)