PALISADE Follow-on Study (ARC004)

March 16, 2022 updated by: Aimmune Therapeutics, Inc.

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

388

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1G5
        • Triple A Lab
      • Mississauga, Ontario, Canada, L5A 3V4
        • Cheema Research Inc.
      • Ottawa, Ontario, Canada, K1G 6C6
        • Ottawa Allergy Research Corp
      • Toronto, Ontario, Canada, M4V 1R2
        • Gordon Sussman Clinical Research, Inc.
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Montreal Children's Hospital
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitaetsmedizin Berlin
      • Frankfurt am Main, Germany, 60590
        • University of Frankfurt
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Cork University Hospital
  • Italy
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Groningen, Netherlands, 9700 RB
        • Beatrix Children's Hospital, University Medical Center Groningen
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28009
        • H. Infantil Universitario Niño Jesús
  • Sweden
      • Stockholm, Sweden, 118 83
        • Sachsska Children and Youth Hospital
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guy & St Thomas' NHS foundation Trust
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals, NHS Foundation Trust
      • Manchester, United Kingdom, M23 9LT
        • Central Manchester University Hospitals, NHS Foundation Trust
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Banner University of Arizona Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Mission Viejo, California, United States, 92691
        • Allergy & Asthma Associates of Southern California
      • Mountain View, California, United States, 94040
        • Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates, Inc.
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group and Research Center, APC
      • San Diego, California, United States, 92123
        • Rady Children's Hospital, San Diego
      • San Francisco, California, United States, 94158
        • University of California, San Francisco
      • Santa Monica, California, United States, 90404
        • UCLA Medical Center, Santa Monica
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Centennial, Colorado, United States, 80122
        • Colorado Allergy & Asthma Centers, P.C.
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
      • Tampa, Florida, United States, 33613
        • University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Atlanta Allergy & Asthma Clinic, PA
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Idaho Allergy and Research, dba Idaho Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60637
        • Comer Children's Hospital
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze, & Itch Associates, LLC
    • Indiana
      • Carmel, Indiana, United States, 46032
        • IU North Riley Children's Specialist
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21236
        • Chesapeake Clinical Research, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital, Div. of Allergy & Immunology
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine, Michigan Clinical Research Unit
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute, Inc.
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Children's Mercy on Broadway
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Nebraska Medical Research Institute Inc.
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Atlantic Research Center, LLC
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai, Clinical Research Unit
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
      • Charlotte, North Carolina, United States, 28277
        • Clinical Research of Charlotte
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Oregon
      • Portland, Oregon, United States, 97223
        • Baker Allergy, Asthma & Dermatology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • National Allergy and Asthma Research, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Le Bonheur Children's Hospital - Outpatient Building
    • Texas
      • Austin, Texas, United States, 78723
        • 'Specially for Children Allergy, Asthma and Immunology Clinic
      • Dallas, Texas, United States, 75235
        • Children's Health
      • El Paso, Texas, United States, 79903
        • Western Sky Medical Research
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital, Baylor College of Medicine
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78229
        • Sylvana Research Associates
    • Washington
      • Seattle, Washington, United States, 98115
        • Asthma Inc Clinical Research Center
      • Seattle, Washington, United States, 98101
        • Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 126 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 126 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aimmune Therapeutics, Inc.

Investigators

  • Study Director: Director of Regulatory Affairs, Aimmune Regulatory Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2016

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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