PALISADE Follow-on Study (ARC004)
- Conditions
- Peanut Allergy
- Interventions
- Biological: AR101
- Registration Number
- NCT02993107
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (Placebo Crossovers) AR101 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). Group 2 (Active Rollovers) AR101 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.
- Primary Outcome Measures
Name Time Method Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) 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
Name Time Method Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) 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).
Trial Locations
- Locations (64)
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
🇺🇸Mountain View, California, United States
Atlanta Allergy & Asthma Clinic, PA
🇺🇸Marietta, Georgia, United States
Cheema Research Inc.
🇨🇦Mississauga, Ontario, Canada
UCLA Medical Center, Santa Monica
🇺🇸Santa Monica, California, United States
Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Boston Children's Hospital, Div. of Allergy & Immunology
🇺🇸Boston, Massachusetts, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, 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
National Jewish Health
🇺🇸Denver, Colorado, United States
Baker Allergy, Asthma & Dermatology
🇺🇸Portland, Oregon, United States
Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Asthma Inc Clinical Research Center
🇺🇸Seattle, Washington, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Beatrix Children's Hospital, University Medical Center Groningen
🇳🇱Groningen, Netherlands
National Allergy and Asthma Research, LLC
🇺🇸Charleston, South Carolina, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Health
🇺🇸Dallas, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Ottawa Allergy Research Corp
🇨🇦Ottawa, Ontario, Canada
Charité Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
H. Infantil Universitario Niño Jesús
🇪🇸Madrid, Spain
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Sachsska Children and Youth Hospital
🇸🇪Stockholm, Sweden
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Montreal Children's Hospital
🇨🇦Montréal, Quebec, Canada
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Central Manchester University Hospitals, NHS Foundation Trust
🇬🇧Manchester, United Kingdom
University of Frankfurt
🇩🇪Frankfurt am Main, Germany
Le Bonheur Children's Hospital - Outpatient Building
🇺🇸Memphis, Tennessee, United States
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
🇺🇸New York, New York, United States
'Specially for Children Allergy, Asthma and Immunology Clinic
🇺🇸Austin, Texas, United States
Texas Children's Hospital, Baylor College of Medicine
🇺🇸Houston, Texas, United States
Guy & St Thomas' NHS foundation Trust
🇬🇧London, United Kingdom
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Gordon Sussman Clinical Research, Inc.
🇨🇦Toronto, Ontario, Canada
University of California, San Francisco
🇺🇸San Francisco, California, United States
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Peninsula Research Associates, Inc.
🇺🇸Rolling Hills Estates, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Colorado Allergy & Asthma Centers, P.C.
🇺🇸Centennial, Colorado, United States
Idaho Allergy and Research, dba Idaho Research
🇺🇸Eagle, Idaho, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
🇺🇸Tampa, Florida, United States
Sneeze, Wheeze, & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
IU North Riley Children's Specialist
🇺🇸Carmel, Indiana, United States
Clinical Research Institute, Inc.
🇺🇸Plymouth, Minnesota, United States
Michigan Medicine, Michigan Clinical Research Unit
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy on Broadway
🇺🇸Kansas City, Missouri, United States
Nebraska Medical Research Institute Inc.
🇺🇸Bellevue, Nebraska, United States
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
Cork University Hospital
🇮🇪Cork, Ireland
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Triple A Lab
🇨🇦Hamilton, Ontario, Canada