Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
NCT ID: NCT02635776
Last Updated: 2022-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2015-12-22
2018-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AR101 powder provided in capsules & sachets
Study product provided as peanut protein in pull-apart capsules or sachets
AR101 powder provided in capsules & sachets
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules & sachets
Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients
Placebo powder provided in capsules & sachets
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Interventions
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AR101 powder provided in capsules & sachets
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules & sachets
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
4 Years
55 Years
ALL
No
Sponsors
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Aimmune Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Director of Regulatory Affairs
Role: STUDY_CHAIR
Aimmune Therapeutics, Inc.
Locations
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Banner University of Arizona Medical Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
Long Beach, California, United States
UCLA Medical Center, Santa Monica
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, United States
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
Mountain View, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, 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
University of California, San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Colorado Allergy & Asthma Centers, P.C.
Centennial, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Windom Allergy, Asthma and Sinus
Sarasota, Florida, 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
Idaho Allergy LLC dba Idaho Research
Eagle, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Comer Children's Hospital
Chicago, Illinois, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
IU North Riley Children's Specialists
Carmel, Indiana, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Clinical Research Institute Inc.
Plymouth, Minnesota, United States
Children's Mercy on Broadway
Kansas City, Missouri, United States
Asthma & Allergy Center, PC
Bellevue, Nebraska, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, 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
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Baker Allergy Asthma & Dermatology Research Center, LLC
Portland, Oregon, United States
Children's Hospital of Philadelphia: Allergy / Immunology
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research, LLC
Charleston, South Carolina, United States
LeBonheur Children's Hospital - Outpatient Building
Memphis, Tennessee, United States
Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, United States
Allergy Partners of North Texas Research
Dallas, Texas, United States
Children's Medical Center
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Sylvana Research
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Northwest Asthma and Allergy Center
Seattle, Washington, United States
Ohayon
Hamilton, Ontario, Canada
Cheema Research, Inc.
Mississauga, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research, Inc.
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Odense Universitetshospital - Department of Dermatology and Allergy Center
Odense, , Denmark
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
Frankfurt, , Germany
Medaimun GmbH
Frankfurt am Main, , Germany
Cork University Hospital
Cork, , Ireland
Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
Padua, , Italy
Universitair medisch Centrum Groningen
Groningen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Barnforskningscentrum, Sachs' Children and Youth Hospital
Stockholm, , Sweden
Guy and St Thomas' NHS Foundation Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
Manchester, , United Kingdom
Countries
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References
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Nilsson C, Vereda A, Borres MP, Andersson M, Sodergren E, Rudengren M, Smith A, Simon RJ, Ryan R, Fernandez-Rivas M, Adelman D, Vickery BP. Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial. Clin Transl Allergy. 2024 Jan;14(1):e12326. doi: 10.1002/clt2.12326.
Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
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.
Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARC003
Identifier Type: -
Identifier Source: org_study_id
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