AR101 Real-World Open-Label Extension Study

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Study Overview

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

Detailed Description

This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.

• Study Type: Interventional
• Enrollment (Actual): 243
• 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 / Hamilton Allergy
    • Mississauga, Ontario, Canada, L5A 3V4
      • Cheema Research Inc. (CRI)
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Research Corp
    • Toronto, Ontario, Canada, M4V 1R2
      • Gordon Sussman Clinical Research
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Medical Research of Arizona
    • Tucson, Arizona, United States, 85724
      • Banner University 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.
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California
    • Mountain View, California, United States, 94040
      • Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
    • 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. Allergy & Immunology, UC San Diego
    • 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 Medical Center
  • 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 Windom Allergy, Asthma and Sinus
    • Tampa, Florida, United States, 33613
      • University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
  • Georgia
    • 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, LLC
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic Downtown
  • 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
      • University of Michigan Division 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
    • 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
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73131
      • Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Columbia Asthma & Allergy Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
  • Texas
    • 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
  • 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: 4 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Received AR101 in study ARC007
• Completed the ARC007 study
• Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

• Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
• Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
• Currently in the build-up phase of immunotherapy for any nonfood allergen.
• Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Treatment arm description; Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.	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 (Safety and Tolerability)	Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)	Approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events		Approximately 6 months
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events		Approximately 6 months
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing		Approximately 6 months
Number of Participants With Allergic Hypersensitivity Adverse Events		Approximately 6 months
Number of Participants With of Anaphylaxis as Defined in the Protocol	Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence).; Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain).; Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or > 30% drop in systolic BP; Adults: systolic BP < 90 mm Hg or > 30% drop from their baseline.	Approximately 6 months
Number of Participants With Epinephrine Use as Rescue Medication		Approximately 6 months
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods	Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.	Approximately 6 months
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11	The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).	Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17	The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).	Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Number of Participants With Adverse Events That Led to Early Withdrawal		Approximately 6 months

Collaborators and Investigators

• Sponsor: Aimmune Therapeutics, Inc.

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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2017
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ACTUAL): September 20, 2019

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (ACTUAL): November 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Peanut Allergy; AR101; Peanut-Allergic Children; Desensitization; OIT (oral immunotherapy); Food Allergy; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen)
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: ARC011

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