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

Peanut Allergy Clinical Trial

— PALISADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635776
• Other study ID #: ARC003
• Status: Completed
• Phase: Phase 3
• Start date: December 22, 2015
• Est. completion date: July 2, 2018

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 efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

Description:

This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: July 2, 2018
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101 powder provided in capsules & sachets
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
• Placebo powder provided in capsules & sachets
Study product formulated to contain only inactive ingredients for use as defined in the protocol

Locations

Country	Name	City	State
Canada	Ohayon	Hamilton	Ontario
Canada	Cheema Research, Inc.	Mississauga	Ontario
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Gordon Sussman Clinical Research, Inc.	Toronto	Ontario
Denmark	Odense Universitetshospital - Department of Dermatology and Allergy Center	Odense
Germany	Charite Universitaetsmedizin Berlin	Berlin
Germany	Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin	Frankfurt
Germany	Medaimun GmbH	Frankfurt am Main
Ireland	Cork University Hospital	Cork
Italy	Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,	Padova
Netherlands	Universitair medisch Centrum Groningen	Groningen
Netherlands	University Medical Center Groningen	Groningen
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Infantil Universitario Nino Jesus	Madrid
Sweden	Barnforskningscentrum, Sachs' Children and Youth Hospital	Stockholm
United Kingdom	Guy and St Thomas' NHS Foundation Trust	London
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester
United Kingdom	University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility	Manchester
United States	University of Michigan Health System	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	John Hopkins Hospital	Baltimore	Maryland
United States	Asthma & Allergy Center, PC	Bellevue	Nebraska
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	IU North Riley Children's Specialists	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	Allergy Partners of North Texas Research	Dallas	Texas
United States	Children's Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Idaho Allergy LLC dba Idaho Research	Eagle	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Mercy on Broadway	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Long Beach Memorial Medical Center / Miller Children's and Women's Hospital	Long Beach	California
United States	UCLA Medical Center, Santa Monica	Los Angeles	California
United States	Atlanta Allergy & Asthma Clinic, PA	Marietta	Georgia
United States	LeBonheur Children's Hospital - Outpatient Building	Memphis	Tennessee
United States	Allergy & Asthma Associates of Southern California dba Southern California Research	Mission Viejo	California
United States	Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital	Mountain View	California
United States	Columbia University Medical Center	New York	New York
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	Children's Hospital of Philadelphia: Allergy / Immunology	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 Research Center, LLC	Portland	Oregon
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	Sylvana Research	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research Center, A.P.C	San Diego	California
United States	Rady Children's Hospital	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Windom Allergy, Asthma and Sinus	Sarasota	Florida
United States	Northwest Asthma and Allergy Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	University of South Florida Asthma, Allergy & 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,  Denmark,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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	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)	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	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)	The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (Severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower).	12 months