PALISADE Follow-on Study (ARC004)

Peanut Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993107
• Other study ID #: ARC004
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: March 2022
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101
AR101 powder provided in capsules & sachets

Locations

Country	Name	City	State
Canada	Triple A Lab	Hamilton	Ontario
Canada	Cheema Research Inc.	Mississauga	Ontario
Canada	Montreal Children's Hospital	Montréal	Quebec
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Gordon Sussman Clinical Research, Inc.	Toronto	Ontario
Germany	Charité Universitaetsmedizin Berlin	Berlin
Germany	University of Frankfurt	Frankfurt am Main
Ireland	Cork University Hospital	Cork
Italy	Azienda Ospedaliera di Padova	Padova
Netherlands	Beatrix Children's Hospital, University Medical Center Groningen	Groningen
Netherlands	University Medical Center Groningen	Groningen
Spain	H. Infantil Universitario Niño Jesús	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Sweden	Sachsska Children and Youth Hospital	Stockholm
United Kingdom	Guy & St Thomas' NHS foundation Trust	London
United Kingdom	Central Manchester University Hospitals, NHS Foundation Trust	Manchester
United Kingdom	Central Manchester University Hospitals, NHS Foundation Trust	Manchester
United States	Michigan Medicine, Michigan Clinical Research Unit	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	'Specially for Children Allergy, Asthma and Immunology Clinic	Austin	Texas
United States	Chesapeake Clinical Research, Inc.	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Nebraska Medical Research Institute Inc.	Bellevue	Nebraska
United States	Boston Children's Hospital, Div. of Allergy & Immunology	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	IU North Riley Children's Specialist	Carmel	Indiana
United States	Colorado Allergy & Asthma Centers, P.C.	Centennial	Colorado
United States	University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)	Chapel Hill	North Carolina
United States	National Allergy and Asthma Research, LLC	Charleston	South Carolina
United States	Clinical Research of Charlotte	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Comer Children's Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Health	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Idaho Allergy and Research, dba Idaho Research	Eagle	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Texas Children's Hospital, Baylor College of Medicine	Houston	Texas
United States	Children's Mercy on Broadway	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Atlanta Allergy & Asthma Clinic, PA	Marietta	Georgia
United States	Le Bonheur Children's Hospital - Outpatient Building	Memphis	Tennessee
United States	Allergy & Asthma Associates of Southern California	Mission Viejo	California
United States	Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital	Mountain View	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Icahn School of Medicine at Mount Sinai, Clinical Research Unit	New York	New York
United States	Sneeze, Wheeze, & Itch Associates, LLC	Normal	Illinois
United States	Atlantic Research Center, LLC	Ocean City	New Jersey
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Clinical Research Institute, Inc.	Plymouth	Minnesota
United States	Baker Allergy, Asthma & Dermatology	Portland	Oregon
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research Center, APC	San Diego	California
United States	Rady Children's Hospital, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	UCLA Medical Center, Santa Monica	Santa Monica	California
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Asthma Inc Clinical Research Center	Seattle	Washington
United States	Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center	Seattle	Washington
United States	University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit	Tampa	Florida
United States	Banner University of Arizona Medical Center	Tucson	Arizona
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)	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	Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)	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