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PALISADE Follow-on Study (ARC004)

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.
 
ClinicalTrials.gov Identifier: NCT02993107
Recruitment Status : Completed
First Posted : December 15, 2016
Results First Posted : December 15, 2021
Last Update Posted : March 17, 2022
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 oral immunotherapy (OIT) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 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
Actual Study Start Date : December 29, 2016
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

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. Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) [ Time Frame: Up to 126 weeks ]
    Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).


Secondary Outcome Measures :
  1. Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) [ Time Frame: Up to 126 weeks ]
    The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).



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:

  • 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

Key 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


Locations
Show Show 65 study locations
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
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Study Director: Director of Regulatory Affairs Aimmune Regulatory Affairs
  Study Documents (Full-Text)

Documents provided by Aimmune Therapeutics, Inc.:
Study Protocol  [PDF] April 12, 2018
Statistical Analysis Plan  [PDF] July 10, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02993107    
Other Study ID Numbers: ARC004
First Posted: December 15, 2016    Key Record Dates
Results First Posted: December 15, 2021
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate