PALISADE Follow-on Study (ARC004)

NCT02993107 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARC004
• Study Type: interventional
• Target: 388
• Locations: 9 countries
• Sites: 65

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.

Conditions

Peanut Allergy

Keywords

AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization; PALISADE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)

  Up to 126 weeks

Study Arms (2)

Group 1 (Placebo Crossovers)

OTHER

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

Group 2 (Active Rollovers)

OTHER

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

Interventions

AR101 BIOLOGICAL

AR101 powder provided in capsules \& sachets

Group 1 (Placebo Crossovers); Group 2 (Active Rollovers)

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Early discontinuation from the ARC003 study
• (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

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (65)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital

Mountain View, California, 94040, United States

Location

Peninsula Research Associates, Inc.

Rolling Hills Estates, California, 90274, United States

Location

Allergy & Asthma Medical Group and Research Center, APC

San Diego, California, 92123, United States

Location

Rady Children's Hospital, San Diego

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Colorado Allergy & Asthma Centers, P.C.

Centennial, Colorado, 80122, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Sarasota Clinical Research

Sarasota, Florida, 34239, United States

Location

University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit

Tampa, Florida, 33613, United States

Location

Atlanta Allergy & Asthma Clinic, PA

Marietta, Georgia, 30060, United States

Location

Idaho Allergy and Research, dba Idaho Research

Eagle, Idaho, 83616, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

IU North Riley Children's Specialist

Carmel, Indiana, 46032, United States

Location

Chesapeake Clinical Research, Inc.

Baltimore, Maryland, 21236, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital, Div. of Allergy & Immunology

Boston, Massachusetts, 02115, United States

Location

Michigan Medicine, Michigan Clinical Research Unit

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute, Inc.

Plymouth, Minnesota, 55441, United States

Location

Children's Mercy on Broadway

Kansas City, Missouri, 64111, United States

Location

Nebraska Medical Research Institute Inc.

Bellevue, Nebraska, 68123, United States

Location

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712, United States

Location

Icahn School of Medicine at Mount Sinai, Clinical Research Unit

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)

Chapel Hill, North Carolina, 27599, United States

Location

Clinical Research of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Baker Allergy, Asthma & Dermatology

Portland, Oregon, 97223, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

National Allergy and Asthma Research, LLC

Charleston, South Carolina, 29407, United States

Location

Le Bonheur Children's Hospital - Outpatient Building

Memphis, Tennessee, 38105, United States

Location

'Specially for Children Allergy, Asthma and Immunology Clinic

Austin, Texas, 78723, United States

Location

Children's Health

Dallas, Texas, 75235, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Asthma Inc Clinical Research Center

Seattle, Washington, 98115, United States

Location

Triple A Lab

Hamilton, Ontario, L8S 1G5, Canada

Location

Cheema Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Ottawa Allergy Research Corp

Ottawa, Ontario, K1G 6C6, Canada

Location

Gordon Sussman Clinical Research, Inc.

Toronto, Ontario, M4V 1R2, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Charité Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

University of Frankfurt

Frankfurt am Main, 60590, Germany

Location

Cork University Hospital

Cork, T12 DC4A, Ireland

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

H. Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Sachsska Children and Youth Hospital

Stockholm, 118 83, Sweden

Location

Guy & St Thomas' NHS foundation Trust

London, SE1 7EH, United Kingdom

Location

Central Manchester University Hospitals, NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Central Manchester University Hospitals, NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (2)

• Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.

  PMID: 36915184 DERIVED

• Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.

  PMID: 34389504 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Aimmune Therapeutics, Inc.

RegulatoryAffairs@aimmune.com

650-409-5164

Study Officials

• Director of Regulatory Affairs

  Aimmune Regulatory Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: December 29, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: March 17, 2022
• Results First Posted: December 15, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); SE (1); IT (1); DE (2); IE (1); GB (3); ES (3); CA (5); US (47)