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AR101 Real-World Open-Label Extension Study

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AR101
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, Food Allergy

Eligibility Criteria

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

Key Inclusion Criteria:

  • Received AR101 in study ARC007
  • Completed the ARC007 study
  • Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

  • Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
  • Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
  • Currently in the build-up phase of immunotherapy for any nonfood allergen.
  • Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

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.
  • Allergy & Asthma Associates of Southern California
  • Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
  • Peninsula Research Associates
  • Allergy & Asthma Medical Group and Research Center
  • Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
  • UCSF, Benioff Children's Hospital - Allergy and Immunology
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
  • UCLA Medical Center, Santa Monica
  • Bay Area Allergy
  • Children's Hospital Colorado
  • Asthma & Allergy Associates
  • National Jewish Health
  • Colorado Allergy & Asthma Centers, P.C.
  • Children's National Medical Center
  • Sher Allergy Specialists - Center for Cough
  • Allergy Associates of the Palm Beaches
  • Sarasota Clinical Research Windom Allergy, Asthma and Sinus
  • University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
  • Atlanta Allergy & Asthma Clinic
  • Idaho Allergy and Research
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • The University of Chicago Medicine, Comer Children's Hospital
  • Sneeze, Wheeze, & Itch Associates, LLC
  • Deaconess Clinic Downtown
  • 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 Division of Allergy and Clinical Immunology
  • Clinical Research Institute, Inc.
  • Children's Mercy on Broadway
  • Atlantic Research Center
  • Princeton Center for Clinical Research
  • Northwell Health System
  • Univ. of Rochester Medical Center, Golisano Children's Hosp.
  • University of North Carolina at Chapel Hill, Clinical & Translational Research Center
  • 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
  • The Children's Hospital of Philadelphia
  • National Allergy and Asthma Research, LLC
  • Specially for Children Allergy, Asthma and Immunology Clinic
  • Children's Health
  • Western Sky Medical Research
  • Texas Children's Hospital, Baylor College of Medicine
  • Virginia Mason Medical Center
  • ASTHMA Inc. Clinical Research Center
  • McMaster University Medical Center
  • Triple A Lab / Hamilton Allergy
  • Cheema Research Inc. (CRI)
  • Ottawa Allergy Research Corp
  • Gordon Sussman Clinical Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment arm description

Arm Description

Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)

Secondary Outcome Measures

Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Number of Participants With Allergic Hypersensitivity Adverse Events
Number of Participants With 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.
Number of Participants With Epinephrine Use as Rescue Medication
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11
The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17
The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).
Number of Participants With Adverse Events That Led to Early Withdrawal

Full Information

First Posted
November 6, 2017
Last Updated
October 5, 2021
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03337542
Brief Title
AR101 Real-World Open-Label Extension Study
Official Title
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (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
No

5. Study Description

Brief Summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Detailed Description
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.

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, Food Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm description
Arm Type
Other
Arm Description
Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.
Intervention Type
Biological
Intervention Name(s)
AR101
Intervention Description
AR101
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
Time Frame
Approximately 6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
Time Frame
Approximately 6 months
Title
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Time Frame
Approximately 6 months
Title
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Time Frame
Approximately 6 months
Title
Number of Participants With Allergic Hypersensitivity Adverse Events
Time Frame
Approximately 6 months
Title
Number of Participants With 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
Number of Participants With Epinephrine Use as Rescue Medication
Time Frame
Approximately 6 months
Title
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
Description
Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Time Frame
Approximately 6 months
Title
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11
Description
The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).
Time Frame
Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Title
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17
Description
The ACT for subjects aged 12 to 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, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Title
Number of Participants With 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: Received AR101 in study ARC007 Completed the ARC007 study Use of effective birth control by sexually active female subjects of childbearing potential Key Exclusion Criteria: Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study. Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy. Currently in the build-up phase of immunotherapy for any nonfood allergen. Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Therapeutics
Official's Role
Study Director
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
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 at Stanford University - Packard-El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF, Benioff Children's Hospital - Allergy and Immunology
City
San Francisco
State/Province
California
ZIP/Postal Code
95148
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
Bay Area Allergy
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
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
Country
United States
Facility Name
Colorado Allergy & Asthma Centers, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Children's National Medical Center
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 Windom Allergy, Asthma and Sinus
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
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 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
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 Division of Allergy and Clinical Immunology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
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
Atlantic Research Center
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
Univ. of Rochester Medical Center, Golisano Children's Hosp.
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
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
National Allergy and Asthma Research, LLC
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Specially for Children Allergy, Asthma and 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
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
98115-2024
Country
United States
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Triple A Lab / Hamilton Allergy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
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

AR101 Real-World Open-Label Extension Study

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