Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) (PALISADE)

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.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Biological: AR101 powder provided in capsules & sachets; Biological: Placebo powder provided in capsules & sachets

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.

• Study Type: Interventional
• Enrollment (Actual): 555
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1G5
      • Ohayon
    • Mississauga, Ontario, Canada, L5A 3V4
      • Cheema Research, Inc.
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Research Corp
    • Toronto, Ontario, Canada, M4V 1R2
      • Gordon Sussman Clinical Research, Inc.
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • Montreal Children's Hospital
• Denmark
  • Odense, Denmark, DK5000
    • Odense Universitetshospital - Department of Dermatology and Allergy Center
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin
  • Frankfurt, Germany, 60590
    • Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
  • Frankfurt am Main, Germany, 60596
    • Medaimun GmbH
• Ireland
  • Cork, Ireland
    • Cork University Hospital
• Italy
  • Padova, Italy, 35128
    • Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
• Netherlands
  • Groningen, Netherlands, 9713GZ
    • University Medical Center Groningen
  • Groningen, Netherlands, 9713GZ
    • Universitair Medisch Centrum Groningen
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Niño Jesús
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
• Sweden
  • Stockholm, Sweden, 118 83
    • Barnforskningscentrum, Sachs' Children and Youth Hospital
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy and St Thomas' NHS Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Central Manchester University Hospitals NHS Foundation Trust
  • Manchester, United Kingdom, M23 9LT
    • University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Banner University of Arizona Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
    • Los Angeles, California, United States, 90404
      • UCLA Medical Center, Santa Monica
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California dba Southern California Research
    • Mountain View, California, United States, 94040
      • Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates, Inc.
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center, A.P.C
    • San Francisco, California, United States, 94158
      • University of California, San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Centennial, Colorado, United States, 80112
      • Colorado Allergy & Asthma Centers, P.C.
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Sarasota, Florida, United States, 34239
      • Windom Allergy, Asthma and Sinus
    • Tampa, Florida, United States, 33613
      • University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Atlanta Allergy & Asthma Clinic, PA
  • Idaho
    • Eagle, Idaho, United States, 83616
      • Idaho Allergy LLC dba Idaho Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60637
      • Comer Children's Hospital
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze & Itch Associates, LLC
  • Indiana
    • Carmel, Indiana, United States, 46032
      • IU North Riley Children's Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Hospital
    • Baltimore, Maryland, United States, 21236
      • Chesapeake Clinical Research, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute Inc.
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Children's Mercy on Broadway
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Asthma & Allergy Center, PC
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai, Clinical Research Unit
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
    • Charlotte, North Carolina, United States, 28277
      • Clinical Research of Charlotte
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Oregon
    • Portland, Oregon, United States, 97223
      • Baker Allergy Asthma & Dermatology Research Center, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia: Allergy / Immunology
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • National Allergy and Asthma Research, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • LeBonheur Children's Hospital - Outpatient Building
  • Texas
    • Austin, Texas, United States, 78723
      • Specially for Children Allergy, Asthma and Immunology Clinic
    • Dallas, Texas, United States, 75230
      • Allergy Partners of North Texas Research
    • Dallas, Texas, United States, 75235
      • Children's Medical Center
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • San Antonio, Texas, United States, 78229
      • Sylvana Research
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98115
      • Northwest Asthma and Allergy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR101 powder provided in capsules & sachets; Study product provided as peanut protein in pull-apart capsules or sachets	Biological: 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 Comparator: Placebo powder provided in capsules & sachets; Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients	Biological: Placebo powder provided in capsules & sachets; Study product formulated to contain only inactive ingredients for use as defined in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	12 months
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)	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.	12 months
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)	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).	12 months

Collaborators and Investigators

• Sponsor: Aimmune Therapeutics, Inc.
• Investigators: Study Chair: Director of Regulatory Affairs, Aimmune Therapeutics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2015
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): July 2, 2018

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Allergy; Peanut Allergy; Peanut-Allergic Children; Desensitization; OIT (oral immunotherapy); Oral Immunotherapy; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); Peanut-Allergic Adults; AR101 (Characterized Peanut Allergen)
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: ARC003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No