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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02635776
First Posted: December 21, 2015
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Peanut Allergy Biological: AR101 powder provided in capsules & sachets Biological: Placebo powder provided in capsules & sachets Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

Resource links provided by NLM:


Further study details as provided by Aimmune Therapeutics, Inc.:

Primary Outcome Measures:
  • Peanut allergy desensitization [ Time Frame: 12 months ]
    The proportion of subjects ages 4 to 17 years who tolerate a highest dose of at least 600 mg (1043 mg cumulative) of peanut protein with no more than mild symptoms at the Exit Double-Blind Placebo-Controlled Food Challenge (DBPCFC) (North America)

  • Peanut allergy desensitization [ Time Frame: 12 months ]
    The proportion of subjects ages 4 to 17 years who tolerate a highest dose of at least 1000 mg (2043 mg cumulative) of peanut protein with no more than mild symptoms at the Exit DBPCFC (Europe)


Secondary Outcome Measures:
  • Peanut allergy desensitization [ Time Frame: 12 months ]
    The proportion of subjects ages 4 to 17 years who tolerate a highest dose of at least 300 mg (443 mg cumulative) of peanut protein with no more than mild symptoms at the Exit DBPCFC (North America)

  • Peanut allergy desensitization [ Time Frame: 12 months ]
    The proportion of subjects ages 4 to 17 years who tolerate a highest dose of at least 600 mg (1043 mg cumulative) of peanut protein with no more than mild symptoms at the Exit DBPCFC (Europe)


Estimated Enrollment: 500
Study Start Date: December 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AR101 powder provided in capsules & sachets
Study product provided in pull-apart peanut protein 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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635776


  Hide Study Locations
Locations
United States, Arizona
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
Long Beach, California, United States, 90806
UCLA Medical Center, Santa Monica
Los Angeles, California, United States, 90404
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, United States, 92691
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
Mountain View, California, United States, 94040
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States, 90274
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, United States, 92123
Rady Children's Hospital
San Diego, California, United States, 92123
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Colorado Allergy & Asthma Centers, P.C.
Centennial, Colorado, United States, 80112
National Jewish Health
Denver, Colorado, United States, 80206
United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Windom Allergy, Asthma and Sinus
Sarasota, Florida, United States, 34239
University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, United States, 30060
United States, Idaho
Idaho Allergy LLC dba Idaho Research
Eagle, Idaho, United States, 83616
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Comer Children's Hospital
Chicago, Illinois, United States, 60637
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States, 61761
United States, Indiana
IU North Riley Children's Specialists
Carmel, Indiana, United States, 46032
United States, Maryland
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, United States, 21236
John Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Clinical Research Institute Inc.
Plymouth, Minnesota, United States, 55441
United States, Missouri
Children's Mercy on Broadway
Kansas City, Missouri, United States, 64111
United States, Nebraska
Asthma & Allergy Center, PC
Bellevue, Nebraska, United States, 68123
United States, New Jersey
Atlantic Research Center, LLC
Ocean City, New Jersey, United States, 07712
United States, New York
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States, 27599
Clinical Research of Charlotte
Charlotte, North Carolina, United States, 28277
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Baker Allergy Asthma & Dermatology Research Center, LLC
Portland, Oregon, United States, 97223
United States, Pennsylvania
Children's Hospital of Philadelphia: Allergy / Immunology
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
National Allergy and Asthma Research, LLC
Charleston, South Carolina, United States, 29407
United States, Tennessee
LeBonheur Children's Hospital - Outpatient Building
Memphis, Tennessee, United States, 38105
United States, Texas
Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, United States, 78723
Allergy Partners of North Texas Research
Dallas, Texas, United States, 75230
Children's Medical Center
Dallas, Texas, United States, 75235
Western Sky Medical Research
El Paso, Texas, United States, 79903
Texas Children's Hospital
Houston, Texas, United States, 77030
Sylvana Research
San Antonio, Texas, United States, 78229
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Northwest Asthma and Allergy Center
Seattle, Washington, United States, 98115
Canada, Ontario
Ohayon
Hamilton, Ontario, Canada, L8S 1G5
Cheema Research, Inc.
Mississauga, Ontario, Canada, L5A 3V4
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada, K1G 6C6
Gordon Sussman Clinical Research, Inc.
Toronto, Ontario, Canada, M4V 1R2
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A3J1
Denmark
Odense Universitetshospital - Department of Dermatology and Allergy Center
Sdr. Boulevard 29, Odense, Denmark, DK5000
Germany
Charite Universitaetsmedizin Berlin
Berlin, Germany, 13353
Medaimun GmbH
Frankfurt am Main, Germany, 60596
Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
Frankfurt, Germany, 60590
Ireland
Cork University Hospital
Cork, Ireland
Italy
Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
Padova, Italy, 35128
Netherlands
Universitair medisch Centrum Groningen
Groningen, Netherlands, 9713GZ
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Infantil Universitario Nino Jesus
Madrid, Spain, 28009
Hospital Clinico San Carlos
Madrid, Spain, 28040
Sweden
Barnforskningscentrum, Sachs' Children and Youth Hospital
Stockholm, Sweden, 118 83
United Kingdom
Guy and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
Study Chair: Jerome G. Pinkett, MBA Director, Clinical Operations
  More Information

Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02635776     History of Changes
Other Study ID Numbers: ARC003
First Submitted: December 17, 2015
First Posted: December 21, 2015
Last Update Posted: September 18, 2017
Last Verified: September 2017

Keywords provided by Aimmune Therapeutics, Inc.:
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

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate