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

NCT02635776 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ARC003
• Study Type: interventional
• Target: 555
• Locations: 10 countries
• Sites: 69

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

Conditions

Peanut Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

  The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.

  12 months

Secondary Outcomes (3)

• Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

  12 months

• Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

  12 months

• Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)

  12 months

Study Arms (2)

AR101 powder provided in capsules & sachets

EXPERIMENTAL

Study product provided as peanut protein in pull-apart capsules or sachets

Biological: AR101 powder provided in capsules & sachets

Placebo powder provided in capsules & sachets

PLACEBO COMPARATOR

Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients

Biological: Placebo powder provided in capsules & sachets

Interventions

AR101 powder provided in capsules & sachets BIOLOGICAL

Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

AR101 powder provided in capsules & sachets

Placebo powder provided in capsules & sachets BIOLOGICAL

Study product formulated to contain only inactive ingredients for use as defined in the protocol

Placebo powder provided in capsules & sachets

Eligibility Criteria

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

You may qualify if:

• Age 4 through 55 years
• Clinical history of allergy to peanuts or peanut-containing foods
• Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™\* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
• Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL\*\* guidelines
• Not be residing at the same address as another subject in this or any peanut OIT study
• UniCAP™\*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies
• PRACTALL\*\*: PRACTical issues in ALLergology Joint United States/European Union Initiative

You may not qualify if:

• History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC
• History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
• History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
• History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
• History of steroid medication use
• History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
• Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC
• Having the same place of residence as another subject in the study

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (69)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Long Beach Memorial Medical Center / Miller Children's and Women's Hospital

Long Beach, California, 90806, United States

Location

UCLA Medical Center, Santa Monica

Los Angeles, California, 90404, United States

Location

Allergy & Asthma Associates of Southern California dba Southern California Research

Mission Viejo, California, 92691, United States

Location

Sean N. Parker Center for Allergy Research, LPCH at 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, A.P.C

San Diego, California, 92123, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Colorado Allergy & Asthma Centers, P.C.

Centennial, Colorado, 80112, 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

Windom Allergy, Asthma and Sinus

Sarasota, Florida, 34239, United States

Location

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

Tampa, Florida, 33613, United States

Location

Atlanta Allergy & Asthma Clinic, PA

Marietta, Georgia, 30060, United States

Location

Idaho Allergy LLC 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 Specialists

Carmel, Indiana, 46032, United States

Location

Chesapeake Clinical Research, Inc.

Baltimore, Maryland, 21236, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System

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

Asthma & Allergy Center, PC

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

Columbia University Medical Center

New York, New York, 10032, 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 Research Center, LLC

Portland, Oregon, 97223, United States

Location

Children's Hospital of Philadelphia: Allergy / Immunology

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

LeBonheur 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

Allergy Partners of North Texas Research

Dallas, Texas, 75230, United States

Location

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Sylvana Research

San Antonio, Texas, 78229, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Northwest Asthma and Allergy Center

Seattle, Washington, 98115, United States

Location

Ohayon

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, H4A3J1, Canada

Location

Odense Universitetshospital - Department of Dermatology and Allergy Center

Odense, DK5000, Denmark

Location

Charite Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin

Frankfurt, 60590, Germany

Location

Medaimun GmbH

Frankfurt am Main, 60596, Germany

Location

Cork University Hospital

Cork, Ireland

Location

Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,

Padua, 35128, Italy

Location

Universitair medisch Centrum Groningen

Groningen, 9713GZ, Netherlands

Location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Nino Jesus

Madrid, 28009, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Barnforskningscentrum, Sachs' Children and Youth Hospital

Stockholm, 118 83, Sweden

Location

Guy and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility

Manchester, M23 9LT, United Kingdom

Location

Related Publications (5)

• Nilsson C, Vereda A, Borres MP, Andersson M, Sodergren E, Rudengren M, Smith A, Simon RJ, Ryan R, Fernandez-Rivas M, Adelman D, Vickery BP. Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial. Clin Transl Allergy. 2024 Jan;14(1):e12326. doi: 10.1002/clt2.12326.

  PMID: 38282192 DERIVED

• 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

• Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.

  PMID: 34320250 DERIVED

• PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.

  PMID: 30449234 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Interventions

Capsules

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

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 Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 21, 2015
• Study Start: December 22, 2015
• Primary Completion: December 21, 2017
• Study Completion: July 2, 2018
• Last Updated: March 17, 2022
• Results First Posted: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); DE (3); NL (2); SE (1); US (49); ES (3); IT (1); DK (1); CA (5); IE (1)