Clinical trial NCT03126227: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Official title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peanut Allergy
Keywords: AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Desensitization
ARC007
Characterized Oral Desensitization Immunotherapy (CODIT™)
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 506
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization to AR101 or placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Frequency of Premature Discontinuation of Dosing Due to Adverse Events
timeFrame: Approximately 6 months
measure: Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
timeFrame: Approximately 6 months
measure: Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
timeFrame: Approximately 6 months
measure: Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
timeFrame: Approximately 6 months
measure: Frequency of Anaphylaxis as Defined in the Protocol
timeFrame: Approximately 6 months
measure: Frequency of Epinephrine Use as Rescue Medication
timeFrame: Approximately 6 months
measure: Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods
timeFrame: Approximately 6 months
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Frequency of Adverse Events That Led to Early Withdrawal
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona
state: Arizona
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Jonathan Corren, M.D., Inc.
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Mountain View
country: United States
facility: Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, A.P.C
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates, PC
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers
state: Colorado
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Largo
country: United States
facility: Sher Allergy Specialists - Center for Cough
state: Florida
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
state: Florida
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy and Research
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie's Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine, Comer Children's Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Pediatric Clinical Research Unit
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System / Michigan Medicine
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy on Broadway
state: Missouri
city: Bellevue
country: United States
facility: Nebraska Medical Research Institute, Inc.
state: Nebraska
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health System
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Research of Charlotte
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
state: Oklahoma
city: Clackamas
country: United States
facility: Columbia Asthma & Allergy Clinic
state: Oregon
city: Portland
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia: Allergy/Immunology
state: Pennsylvania
city: Austin
country: United States
facility: Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic
state: Texas
city: Dallas
country: United States
facility: Children's Health
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital / Baylor College of Medicine
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: ASTHMA Inc. Clinical Research Center
state: Washington
city: Hamilton
country: Canada
facility: Triple A Lab (Hamilton Allergy)
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research Inc. (CRI)
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp.
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research
state: Ontario
Study officials:
affiliation: Aimmune Therapeutics, Inc.
name: Director of Regulatory Affairs
role: STUDY_CHAIR
References:
citation: 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.