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Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT03703791
Recruitment Status : Terminated (Sponsor terminated study; no impact on overall benefit risk evaluation of AR101)
First Posted : October 12, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Brief Summary:
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: AR101 Phase 3

Detailed Description:
This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : November 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Group 1 (AR101 Treatment + standard of care)
Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.
Biological: AR101
AR101 powder

No Intervention: Group 2 (Standard of Care Treatment)
Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.



Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 18 months ]
    To assess the health-related quality of life (HRQL) of peanut allergic subjects aged 4-17 years receiving AR101 in combination with standard of care versus standard of care alone for approximately 18 months, using self- and proxy-reported age appropriate versions of the Food Allergy Quality of Life Questionnaire (FAQLQ). The FAQLQ total and domain scores range from 1-7 with higher scores indicative of worse HRQL; with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, Food Anxiety, Allergen Avoidance, and Risk of Accidental Exposure.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 4 through 17 years
  • History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms
  • Positive SPT for peanut
  • Positive serum IgE to peanut
  • Written informed consent from the subject's parent/guardian
  • Written assent from the subject as appropriate
  • Use of effective birth control by sexually active female subjects of childbearing potential

Exclusion Criteria:

  • Uncertain clinical diagnosis of peanut allergy
  • History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
  • Severe persistent asthma or uncontrolled mild or moderate asthma
  • History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, 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
  • History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
  • 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

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): NCT03703791


Locations
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Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 8916
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 8208
Hospital Universitario Severo Ochoa
Leganes, Madrid, Spain, 28911
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 8035
Hospital Infantil Universitario Niño Jesus
Madrid, Spain, 28009
Hospital Universitario Infanta Leonor
Madrid, Spain, 28032
Hospital Clinico San Carlos
Madrid, Spain, 28040
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
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Study Chair: Ruth Bateson Aimmune Therapeutics

Additional Information:
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Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03703791     History of Changes
Other Study ID Numbers: ARC009
2018-000326-58 ( EudraCT Number )
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Aimmune Therapeutics, Inc.:
AR101
Characterized Peanut Allergen CPNA
(Characterized Peanut Allergen) OIT
Peanut Allergy
Allergy
Peanut-Allergic Children
Peanut-Allergic Adolescents
Desensitization
Quality of Life
OIT (oral immunotherapy)
CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)

Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs