Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) (PALISADE)
Peanut Allergy
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring AR101 (Characterized Peanut Allergen), Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Oral Immunotherapy, Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization
Eligibility Criteria
Key Inclusion Criteria:
- 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
UniCAP™*: 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 Exclusion Criteria:
- 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
Sites / Locations
- Banner University of Arizona Medical Center
- Arkansas Children's Hospital
- Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
- UCLA Medical Center, Santa Monica
- Allergy & Asthma Associates of Southern California dba Southern California Research
- 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
- University of California, San Francisco
- Children's Hospital Colorado
- Colorado Allergy & Asthma Centers, P.C.
- National Jewish Health
- Children's National Medical Center
- Windom Allergy, Asthma and Sinus
- University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
- Atlanta Allergy & Asthma Clinic, PA
- Idaho Allergy LLC dba Idaho Research
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Comer Children's Hospital
- Sneeze, Wheeze & Itch Associates, LLC
- IU North Riley Children's Specialists
- Chesapeake Clinical Research, Inc.
- John Hopkins Hospital
- Massachusetts General Hospital
- Boston Children's Hospital
- University of Michigan Health System
- Clinical Research Institute Inc.
- Children's Mercy on Broadway
- Asthma & Allergy Center, PC
- Atlantic Research Center, LLC
- Icahn School of Medicine at Mount Sinai, Clinical Research Unit
- Columbia University Medical Center
- University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
- Clinical Research of Charlotte
- Cincinnati Children's Hospital Medical Center
- Baker Allergy Asthma & Dermatology Research Center, LLC
- Children's Hospital of Philadelphia: Allergy / Immunology
- Children's Hospital of Pittsburgh of UPMC
- National Allergy and Asthma Research, LLC
- LeBonheur Children's Hospital - Outpatient Building
- Specially for Children Allergy, Asthma and Immunology Clinic
- Allergy Partners of North Texas Research
- Children's Medical Center
- Western Sky Medical Research
- Texas Children's Hospital
- Sylvana Research
- Virginia Mason Medical Center
- Northwest Asthma and Allergy Center
- Ohayon
- Cheema Research, Inc.
- Ottawa Allergy Research Corp
- Gordon Sussman Clinical Research, Inc.
- Montreal Children's Hospital
- Odense Universitetshospital - Department of Dermatology and Allergy Center
- Charite Universitaetsmedizin Berlin
- Medaimun GmbH
- Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
- Cork University Hospital
- Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
- Universitair medisch Centrum Groningen
- University Medical Center Groningen
- Hospital General Universitario Gregorio Maranon
- Hospital Infantil Universitario Nino Jesus
- Hospital Clinico San Carlos
- Barnforskningscentrum, Sachs' Children and Youth Hospital
- Guy and St Thomas' NHS Foundation Trust
- Central Manchester University Hospitals NHS Foundation Trust
- University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
AR101 powder provided in capsules & sachets
Placebo powder provided in capsules & sachets
Study product provided as peanut protein in pull-apart capsules or sachets
Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients