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

Peanut Allergy Clinical Trial

— RAMSES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126227
• Other study ID #: ARC007
• Status: Completed
• Phase: Phase 3
• Start date: May 8, 2017
• Est. completion date: September 23, 2018

Study information

• Verified date: October 2021
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: September 23, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101
AR101 powder provided in capsules
• Placebo
Placebo powder provided in capsules

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario
Canada	Triple A Lab (Hamilton Allergy)	Hamilton	Ontario
Canada	Cheema Research Inc. (CRI)	Mississauga	Ontario
Canada	Ottawa Allergy Research Corp.	Ottawa	Ontario
Canada	Gordon Sussman Clinical Research	Toronto	Ontario
United States	University of Michigan Health System / Michigan Medicine	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic	Austin	Texas
United States	Chesapeake Clinical Research, Inc.	Baltimore	Maryland
United States	Johns Hopkins Hospital, Pediatric Clinical Research Unit	Baltimore	Maryland
United States	Nebraska Medical Research Institute, Inc.	Bellevue	Nebraska
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)	Chapel Hill	North Carolina
United States	National Allergy and Asthma Research, LLC	Charleston	North Carolina
United States	Clinical Research of Charlotte	Charlotte	North Carolina
United States	Ann & Robert H. Lurie's Children's Hospital of Chicago	Chicago	Illinois
United States	The University of Chicago Medicine, Comer Children's Hospital	Chicago	Illinois
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Columbia Asthma & Allergy Clinic	Clackamas	Oregon
United States	Asthma & Allergy Associates, PC	Colorado Springs	Colorado
United States	Children's Health	Dallas	Texas
United States	Colorado Allergy & Asthma Centers	Denver	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Idaho Allergy and Research	Eagle	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Northwell Health System	Great Neck	New York
United States	Texas Children's Hospital / Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Children's Mercy on Broadway	Kansas City	Missouri
United States	Sher Allergy Specialists - Center for Cough	Largo	Florida
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy	Los Angeles	California
United States	Jonathan Corren, M.D., Inc.	Los Angeles	California
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	Atlanta Allergy & Asthma Clinic, PA	Marietta	Georgia
United States	Allergy & Asthma Associates of Southern California	Mission Viejo	California
United States	Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital	Mountain View	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Wheeze, & Itch Associates, LLC	Normal	Illinois
United States	Allergy Associates of the Palm Beaches	North Palm Beach	Florida
United States	Atlantic Research Center, LLC	Ocean City	New Jersey
United States	Oklahoma Institute of Allergy and Asthma Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia: Allergy/Immunology	Philadelphia	Pennsylvania
United States	Clinical Research Institute, Inc.	Plymouth	Minnesota
United States	Baker Allergy, Asthma and Dermatology Research Center	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	Biogenics Research Institute	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	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	University of California, San Francisco	San Francisco	California
United States	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California
United States	UCLA Medical Center, Santa Monica	Santa Monica	California
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Medical Research of Arizona	Scottsdale	Arizona
United States	ASTHMA Inc. Clinical Research Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit	Tampa	Florida
United States	Banner University of Arizona Medical Center	Tucson	Arizona
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of Premature Discontinuation of Dosing Due to Adverse Events		Approximately 6 months
Secondary	Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events		Approximately 6 months
Secondary	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
Secondary	Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment		Approximately 6 months
Secondary	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
Secondary	Frequency of Epinephrine Use as Rescue Medication		Approximately 6 months
Secondary	Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods		Approximately 6 months
Secondary	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)
Secondary	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)
Secondary	Frequency of Adverse Events That Led to Early Withdrawal		Approximately 6 months