AR101 Real-World Open-Label Extension Study
- Conditions
- Peanut Allergy
- Interventions
- Biological: AR101
- Registration Number
- NCT03337542
- Lead Sponsor
- Aimmune Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- Received AR101 in study ARC007
- Completed the ARC007 study
- Use of effective birth control by sexually active female subjects of childbearing potential
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm description AR101 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Approximately 6 months Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
- Secondary Outcome Measures
Name Time Method Number of Participants With 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.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 Approximately 6 months Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events Approximately 6 months Number of Participants With Allergic Hypersensitivity Adverse Events Approximately 6 months Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods Approximately 6 months Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Number of Participants With Adverse Events That Led to Early Withdrawal Approximately 6 months Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events Approximately 6 months Number of Participants With Epinephrine Use as Rescue Medication Approximately 6 months 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 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) 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 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) 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).
Trial Locations
- Locations (60)
Allergy Associates of the Palm Beaches
🇺🇸North Palm Beach, Florida, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Bay Area Allergy
🇺🇸Walnut Creek, California, United States
Deaconess Clinic Downtown
🇺🇸Evansville, Indiana, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Specially for Children Allergy, Asthma and Immunology Clinic
🇺🇸Austin, Texas, United States
Triple A Lab / Hamilton Allergy
🇨🇦Hamilton, Ontario, Canada
Ottawa Allergy Research Corp
🇨🇦Ottawa, Ontario, Canada
Asthma & Allergy Associates
🇺🇸Colorado Springs, Colorado, United States
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Clinical Research Institute, Inc.
🇺🇸Plymouth, Minnesota, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center
🇺🇸Chapel Hill, North Carolina, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
McMaster University Medical Center
🇨🇦Hamilton, Ontario, Canada
Allergy & Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
Sher Allergy Specialists - Center for Cough
🇺🇸Largo, Florida, United States
Idaho Allergy and Research
🇺🇸Eagle, Idaho, United States
Sneeze, Wheeze, & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Children's Mercy on Broadway
🇺🇸Kansas City, Missouri, United States
Atlantic Research Center
🇺🇸Ocean City, New Jersey, United States
Univ. of Rochester Medical Center, Golisano Children's Hosp.
🇺🇸Rochester, New York, United States
Children's Health
🇺🇸Dallas, Texas, United States
Jonathan Corren, M.D., Inc.
🇺🇸Los Angeles, California, United States
Johns Hopkins Hospital, Pediatric Clinical Research Unit
🇺🇸Baltimore, Maryland, United States
Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
🇺🇸Mountain View, California, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
UCLA Medical Center, Santa Monica
🇺🇸Santa Monica, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
The University of Chicago Medicine, Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Sarasota Clinical Research Windom Allergy, Asthma and Sinus
🇺🇸Sarasota, Florida, United States
Atlanta Allergy & Asthma Clinic
🇺🇸Marietta, Georgia, United States
Northwell Health System
🇺🇸Great Neck, New York, United States
Columbia Asthma & Allergy Clinic
🇺🇸Clackamas, Oregon, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
National Allergy and Asthma Research, LLC
🇺🇸North Charleston, South Carolina, United States
Cheema Research Inc. (CRI)
🇨🇦Mississauga, Ontario, Canada
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Texas Children's Hospital, Baylor College of Medicine
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
ASTHMA Inc. Clinical Research Center
🇺🇸Seattle, Washington, United States
Allergy & Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
🇺🇸San Diego, California, United States
UCSF, Benioff Children's Hospital - Allergy and Immunology
🇺🇸San Francisco, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Colorado Allergy & Asthma Centers, P.C.
🇺🇸Denver, Colorado, United States
Gordon Sussman Clinical Research
🇨🇦Toronto, Ontario, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, 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
Family Allergy & Asthma Research Institute
🇺🇸Louisville, Kentucky, United States
University of Michigan Division of Allergy and Clinical Immunology
🇺🇸Ann Arbor, Michigan, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
Medical Research of Arizona
🇺🇸Scottsdale, Arizona, United States