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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

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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


  Show 69 Study Locations
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