Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
- Conditions
- Peanut Allergy
- Interventions
- Biological: PlaceboBiological: AR101
- Registration Number
- NCT03126227
- Lead Sponsor
- Aimmune Therapeutics, Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo powder Placebo Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product. AR101 Powder Provided in Capsules AR101 Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
- Primary Outcome Measures
Name Time Method Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events Approximately 6 months 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.
- Secondary Outcome Measures
Name Time Method Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment Approximately 6 months 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 Anaphylaxis as Defined in the Protocol Approximately 6 months Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
1. 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).
2. 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).
3. 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.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 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) 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)
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 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) 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).
Frequency of Adverse Events That Led to Early Withdrawal Approximately 6 months
Trial Locations
- Locations (67)
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
🇺🇸Los Angeles, California, United States
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
🇺🇸Mountain View, California, United States
UCLA Medical Center, Santa Monica
🇺🇸Santa Monica, California, United States
Atlanta Allergy & Asthma Clinic, PA
🇺🇸Marietta, Georgia, United States
Ann & Robert H. Lurie's Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital, Pediatric Clinical Research Unit
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Philadelphia: Allergy/Immunology
🇺🇸Philadelphia, Pennsylvania, United States
Children's Health
🇺🇸Dallas, Texas, United States
Cheema Research Inc. (CRI)
🇨🇦Mississauga, Ontario, Canada
Medical Research of Arizona
🇺🇸Scottsdale, Arizona, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Jonathan Corren, M.D., Inc.
🇺🇸Los Angeles, California, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Peninsula Research Associates, Inc.
🇺🇸Rolling Hills Estates, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
Allergy and Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Asthma & Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Sher Allergy Specialists - Center for Cough
🇺🇸Largo, Florida, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States
Allergy Associates of the Palm Beaches
🇺🇸North Palm Beach, Florida, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
The University of Chicago Medicine, Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Idaho Allergy and Research
🇺🇸Eagle, Idaho, United States
Deaconess Clinic Downtown
🇺🇸Evansville, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Family Allergy & Asthma Research Institute
🇺🇸Louisville, Kentucky, United States
University of Michigan Health System / Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy on Broadway
🇺🇸Kansas City, Missouri, United States
Clinical Research Institute, Inc.
🇺🇸Plymouth, Minnesota, United States
Nebraska Medical Research Institute, Inc.
🇺🇸Bellevue, Nebraska, United States
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
Northwell Health System
🇺🇸Great Neck, New York, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
🇺🇸Chapel Hill, North Carolina, United States
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
National Allergy and Asthma Research, LLC
🇺🇸Charleston, North Carolina, United States
Columbia Asthma & Allergy Clinic
🇺🇸Clackamas, Oregon, United States
Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic
🇺🇸Austin, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Triple A Lab (Hamilton Allergy)
🇨🇦Hamilton, Ontario, Canada
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
McMaster University Medical Center
🇨🇦Hamilton, Ontario, Canada
Gordon Sussman Clinical Research
🇨🇦Toronto, Ontario, Canada
Ottawa Allergy Research Corp.
🇨🇦Ottawa, Ontario, Canada
Allergy & Asthma Medical Group and Research Center, A.P.C
🇺🇸San Diego, California, United States
Rady Children's Hospital San Diego
🇺🇸San Diego, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital / Baylor College of Medicine
🇺🇸Houston, Texas, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
ASTHMA Inc. Clinical Research Center
🇺🇸Seattle, Washington, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Colorado Allergy & Asthma Centers
🇺🇸Denver, Colorado, United States
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Baker Allergy, Asthma and Dermatology Research Center
🇺🇸Portland, Oregon, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
🇺🇸Tampa, Florida, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States