Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES) (RAMSES)

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)

This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.

Study Overview

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

Detailed Description

The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.

• Study Type: Interventional
• Enrollment (Actual): 506
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1G5
      • Triple A Lab (Hamilton Allergy)
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University Medical Center
    • 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.
    • 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 Research, LPCH at El Camino Hospital
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates, Inc.
    • San Diego, California, United States, 92123
      • Rady Children's Hospital San Diego
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center, A.P.C
    • San Francisco, California, United States, 94158
      • University of California, San Francisco
    • 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
      • Allergy and Asthma Clinical Research, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma & Allergy Associates, PC
    • Denver, Colorado, United States, 80206-2761
      • National Jewish Health
    • Denver, Colorado, United States, 80230
      • Colorado Allergy & Asthma Centers
  • 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, and Immunology Clinical Research Unit
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Atlanta Allergy & Asthma Clinic, PA
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Idaho Allergy and Research
  • Illinois
    • Chicago, Illinois, United States, 60611-2605
      • Ann & Robert H. Lurie's Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine, Comer Children's Hospital
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates, LLC
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic Downtown
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • 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, 48109
      • University of Michigan Health System / Michigan Medicine
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute, Inc.
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Children's Mercy on Broadway
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Nebraska Medical Research Institute, Inc.
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
    • 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
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
    • Charleston, North Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
    • 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
    • Portland, Oregon, United States, 97223
      • Baker Allergy, Asthma and Dermatology Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia: Allergy/Immunology
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Group / Allergy, Asthma & 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
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98115
      • 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:

• Ages 4 to 17 years, inclusive
• History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
• Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
• Written informed consent from the subject's parent/guardian
• Written assent from the subject as appropriate (per local regulatory requirements)
• Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

• Subjects in whom the clinical diagnosis of peanut allergy is uncertain
• Severe or uncontrolled asthma
• History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
• History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
• History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
• Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AR101 Powder Provided in Capsules; Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol	Biological: AR101; AR101 powder provided in capsules
Placebo Comparator: Placebo powder; Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.	Biological: Placebo; Placebo powder provided in capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events	Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.	Approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Premature Discontinuation of Dosing Due to Adverse Events		Approximately 6 months
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events		Approximately 6 months
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing		Approximately 6 months
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment		Approximately 6 months
Frequency 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
Frequency of Epinephrine Use as Rescue Medication		Approximately 6 months
Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods		Approximately 6 months
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11	The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control)	Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17	The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).	Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Frequency of Adverse Events That Led to Early Withdrawal		Approximately 6 months

Collaborators and Investigators

• Sponsor: Aimmune Therapeutics, Inc.
• Investigators: Study Chair: Director of Regulatory Affairs, 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): September 23, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 24, 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); Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); ARC007; Characterized Oral Desensitization Immunotherapy (CODIT™)
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: ARC007

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