Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
- Conditions
- Peanut Allergy
- Interventions
- Biological: Placebo powder provided in capsules & sachetsBiological: AR101 powder provided in capsules & sachets
- Registration Number
- NCT02635776
- Lead Sponsor
- Aimmune Therapeutics, Inc.
- Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
- Detailed Description
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 555
- Age 4 through 55 years
- Clinical history of allergy to peanuts or peanut-containing foods
- Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
- Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines
- Not be residing at the same address as another subject in this or any peanut OIT study
UniCAPâ„¢*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies
PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative
Key
- 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 DBPCFC
- History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
- 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 severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
- History of steroid medication use
- History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
- Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC
- Having the same place of residence as another subject in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo powder provided in capsules & sachets Placebo powder provided in capsules & sachets Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients AR101 powder provided in capsules & sachets AR101 powder provided in capsules & sachets Study product provided as peanut protein in pull-apart capsules or sachets
- Primary Outcome Measures
Name Time Method Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) 12 months The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) 12 months The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) 12 months The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) 12 months The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (Severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower).
Trial Locations
- Locations (69)
UCLA Medical Center, Santa Monica
🇺🇸Los Angeles, California, United States
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
🇺🇸Mountain View, California, United States
Allergy & Asthma Medical Group and Research Center, A.P.C
🇺🇸San Diego, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
Windom Allergy, Asthma and Sinus
🇺🇸Sarasota, Florida, United States
Children's Medical Center
🇺🇸Dallas, Texas, United States
Sylvana Research
🇺🇸San Antonio, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
IU North Riley Children's Specialists
🇺🇸Carmel, Indiana, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Philadelphia: Allergy / Immunology
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Colorado Allergy & Asthma Centers, P.C.
🇺🇸Centennial, Colorado, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Idaho Allergy LLC dba Idaho Research
🇺🇸Eagle, Idaho, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Odense Universitetshospital - Department of Dermatology and Allergy Center
🇩🇰Odense, Denmark
Baker Allergy Asthma & Dermatology Research Center, LLC
🇺🇸Portland, Oregon, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
National Allergy and Asthma Research, LLC
🇺🇸Charleston, South Carolina, United States
LeBonheur Children's Hospital - Outpatient Building
🇺🇸Memphis, Tennessee, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Ohayon
🇨🇦Hamilton, Ontario, Canada
Gordon Sussman Clinical Research, Inc.
🇨🇦Toronto, Ontario, Canada
Allergy Partners of North Texas Research
🇺🇸Dallas, Texas, United States
Cheema Research, Inc.
🇨🇦Mississauga, Ontario, Canada
Ottawa Allergy Research Corp
🇨🇦Ottawa, Ontario, Canada
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Cork University Hospital
🇮🇪Cork, Ireland
Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
🇮🇹Padova, Italy
Universitair medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Guy and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
🇬🇧Manchester, United Kingdom
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Barnforskningscentrum, Sachs' Children and Youth Hospital
🇸🇪Stockholm, Sweden
Hospital Infantil Universitario Nino Jesus
🇪🇸Madrid, Spain
Central Manchester University Hospitals NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
🇩🇪Frankfurt, Germany
Medaimun GmbH
🇩🇪Frankfurt am Main, Germany
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Specially for Children Allergy, Asthma and Immunology Clinic
🇺🇸Austin, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Northwest Asthma and Allergy Center
🇺🇸Seattle, Washington, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
🇺🇸Mission Viejo, California, United States
Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
🇺🇸Long Beach, California, United States
Peninsula Research Associates, Inc.
🇺🇸Rolling Hills Estates, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
🇺🇸Tampa, Florida, United States
Atlanta Allergy & Asthma Clinic, PA
🇺🇸Marietta, Georgia, United States
Sneeze, Wheeze & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Clinical Research Institute Inc.
🇺🇸Plymouth, Minnesota, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Asthma & Allergy Center, PC
🇺🇸Bellevue, Nebraska, United States
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
Children's Mercy on Broadway
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
🇺🇸Chapel Hill, North Carolina, United States
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States