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Trial record 1 of 1 for:    NCT02635776
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Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) (PALISADE)

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ClinicalTrials.gov Identifier: NCT02635776
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 17, 2015
First Posted Date  ICMJE December 21, 2015
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE January 8, 2016
Actual Primary Completion Date December 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Official Title  ICMJE Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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, Ibáñez 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, Fernández-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2018)
554
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)
500
Actual Study Completion Date  ICMJE July 2, 2018
Actual Primary Completion Date December 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635776
Other Study ID Numbers  ICMJE ARC003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aimmune Therapeutics, Inc.
Study Sponsor  ICMJE Aimmune Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jerome G. Pinkett, MBA Director, Clinical Operations
PRS Account Aimmune Therapeutics, Inc.
Verification Date August 2019

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