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

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AR101
Placebo
Sponsored by
Aimmune Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARC007, Characterized Oral Desensitization Immunotherapy (CODIT™)

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Center of Alabama
  • Medical Research of Arizona
  • Banner University of Arizona Medical Center
  • Arkansas Children's Hospital
  • Jonathan Corren, M.D., Inc.
  • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
  • Allergy & Asthma Associates of Southern California
  • Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
  • Peninsula Research Associates, Inc.
  • Allergy & Asthma Medical Group and Research Center, A.P.C
  • Rady Children's Hospital San Diego
  • University of California, San Francisco
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
  • UCLA Medical Center, Santa Monica
  • Allergy and Asthma Clinical Research, Inc.
  • Children's Hospital Colorado
  • Asthma & Allergy Associates, PC
  • National Jewish Health
  • Colorado Allergy & Asthma Centers
  • Children's National Health System
  • Sher Allergy Specialists - Center for Cough
  • Allergy Associates of the Palm Beaches
  • Sarasota Clinical Research
  • University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
  • Atlanta Allergy & Asthma Clinic, PA
  • Idaho Allergy and Research
  • Ann & Robert H. Lurie's Children's Hospital of Chicago
  • The University of Chicago Medicine, Comer Children's Hospital
  • Sneeze, Wheeze, & Itch Associates, LLC
  • Deaconess Clinic Downtown
  • University of Iowa
  • Family Allergy & Asthma Research Institute
  • Chesapeake Clinical Research, Inc.
  • Johns Hopkins Hospital, Pediatric Clinical Research Unit
  • Massachusetts General Hospital
  • Boston Children's Hospital
  • University of Michigan Health System / Michigan Medicine
  • Clinical Research Institute, Inc.
  • Children's Mercy on Broadway
  • Nebraska Medical Research Institute, Inc.
  • Atlantic Research Center, LLC
  • Princeton Center for Clinical Research
  • Northwell Health System
  • University of Rochester Medical Center
  • University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
  • National Allergy and Asthma Research, LLC
  • Clinical Research of Charlotte
  • Cincinnati Children's Hospital Medical Center
  • Bernstein Clinical Research Center
  • Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
  • Columbia Asthma & Allergy Clinic
  • Baker Allergy, Asthma and Dermatology Research Center
  • Children's Hospital of Philadelphia: Allergy/Immunology
  • Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic
  • Children's Health
  • Western Sky Medical Research
  • Texas Children's Hospital / Baylor College of Medicine
  • Central Texas Health Research
  • Biogenics Research Institute
  • Sylvana Research Associates
  • Virginia Mason Medical Center
  • ASTHMA Inc. Clinical Research Center
  • Triple A Lab (Hamilton Allergy)
  • McMaster University Medical Center
  • Cheema Research Inc. (CRI)
  • Ottawa Allergy Research Corp.
  • Gordon Sussman Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AR101 Powder Provided in Capsules

Placebo powder

Arm Description

Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency of Premature Discontinuation of Dosing Due to Adverse Events
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
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.
Frequency of Epinephrine Use as Rescue Medication
Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods
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)
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).
Frequency of Adverse Events That Led to Early Withdrawal

Full Information

First Posted
April 20, 2017
Last Updated
October 5, 2021
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03126227
Brief Title
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Acronym
RAMSES
Official Title
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aimmune Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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™)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2:1 randomization to AR101 or placebo
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR101 Powder Provided in Capsules
Arm Type
Active Comparator
Arm Description
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Arm Title
Placebo powder
Arm Type
Placebo Comparator
Arm Description
Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.
Intervention Type
Biological
Intervention Name(s)
AR101
Intervention Description
AR101 powder provided in capsules
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo powder provided in capsules
Primary Outcome Measure Information:
Title
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
Description
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.
Time Frame
Approximately 6 months
Secondary Outcome Measure Information:
Title
Frequency of Premature Discontinuation of Dosing Due to Adverse Events
Time Frame
Approximately 6 months
Title
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
Time Frame
Approximately 6 months
Title
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
Time Frame
Approximately 6 months
Title
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
Time Frame
Approximately 6 months
Title
Frequency of Anaphylaxis as Defined in the Protocol
Description
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.
Time Frame
Approximately 6 months
Title
Frequency of Epinephrine Use as Rescue Medication
Time Frame
Approximately 6 months
Title
Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods
Time Frame
Approximately 6 months
Title
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
Description
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)
Time Frame
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)
Title
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
Description
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).
Time Frame
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)
Title
Frequency of Adverse Events That Led to Early Withdrawal
Time Frame
Approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Medical Research of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Banner University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Jonathan Corren, M.D., Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Peninsula Research Associates, Inc.
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center, A.P.C
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
UCLA Medical Center, Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Asthma & Allergy Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206-2761
Country
United States
Facility Name
Colorado Allergy & Asthma Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sher Allergy Specialists - Center for Cough
City
Largo
State/Province
Florida
ZIP/Postal Code
33778
Country
United States
Facility Name
Allergy Associates of the Palm Beaches
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic, PA
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Idaho Allergy and Research
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Ann & Robert H. Lurie's Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2605
Country
United States
Facility Name
The University of Chicago Medicine, Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Family Allergy & Asthma Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Johns Hopkins Hospital, Pediatric Clinical Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System / Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Children's Mercy on Broadway
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Nebraska Medical Research Institute, Inc.
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Atlantic Research Center, LLC
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Northwell Health System
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
National Allergy and Asthma Research, LLC
City
Charleston
State/Province
North Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Clinical Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Columbia Asthma & Allergy Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Baker Allergy, Asthma and Dermatology Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Children's Hospital of Philadelphia: Allergy/Immunology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Texas Children's Hospital / Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
ASTHMA Inc. Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Triple A Lab (Hamilton Allergy)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Cheema Research Inc. (CRI)
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Ottawa Allergy Research Corp.
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Gordon Sussman Clinical Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34389504
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.
Results Reference
derived

Learn more about this trial

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

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