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PALISADE Follow-on Study (ARC004)

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ClinicalTrials.gov Identifier: NCT02993107
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Brief Summary:
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children and adults who have completed the ARC003 study.

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

Detailed Description:
This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 Adults (PALISADE) Follow-on Study
Study Start Date : December 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Group 1 (Placebo Crossovers)
Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
Biological: AR101
AR101 powder provided in capsules & sachets

Group 2 (Active Rollovers)
Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.
Biological: AR101
AR101 powder provided in capsules & sachets




Primary Outcome Measures :
  1. Incidence of adverse events including serious adverse events (Safety and Tolerability) [ Time Frame: 38 months ]
    The frequency of treatment-related adverse events and serious adverse events during the overall study period



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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

Inclusion Criteria:

  • Completion of the ARC003 study
  • Written informed consent and/or assent from subjects/guardians as appropriate
  • Use of effective birth control by sexually active female subjects of child-bearing potential

Exclusion Criteria:

  • Early discontinuation from the ARC003 study
  • Meets any longitudinally applicable ARC003 study exclusion criteria
  • (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
  • Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

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): NCT02993107


Contacts
Contact: Jerome G. Pinkett, MBA 650-362-8705

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Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
Study Chair: Jerome G. Pinkett, MBA Sr. Director, Clinical Operations

Additional Information:
Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02993107     History of Changes
Other Study ID Numbers: ARC004
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Keywords provided by Aimmune Therapeutics, Inc.:
AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Allergy
Peanut-Allergic Children
Peanut-Allergic Adults
Desensitization
PALISADE

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