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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.
December 17, 2015
December 21, 2015
September 18, 2017
December 2015
November 2017   (Final data collection date for primary outcome measure)
  • 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)
Peanut allergy desensitization [ Time Frame: 12 months ]
The proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC)
Complete list of historical versions of study NCT02635776 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Not Provided
Not Provided
 
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Peanut Allergy
  • 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
  • Biological: Placebo powder provided in capsules & sachets
    Study product formulated to contain only inactive ingredients for use as defined in the protocol
  • Experimental: AR101 powder provided in capsules & sachets
    Study product provided in pull-apart peanut protein capsules or sachets
    Intervention: Biological: AR101 powder provided in capsules & sachets
  • Placebo Comparator: Placebo powder provided in capsules & sachets
    Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients
    Intervention: Biological: Placebo powder provided in capsules & sachets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
November 2017
November 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 55 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT02635776
ARC003
Yes
Not Provided
Not Provided
Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc.
Not Provided
Study Chair: Jerome G. Pinkett, MBA Director, Clinical Operations
Aimmune Therapeutics, Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP