Clinical trial NCT02635776: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Official title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 555
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 12 months
Secondary outcomes:
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California dba Southern California Research
state: California
city: Mountain View
country: United States
facility: Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, A.P.C
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Centennial
country: United States
facility: Colorado Allergy & Asthma Centers, P.C.
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Sarasota
country: United States
facility: Windom Allergy, Asthma and Sinus
state: Florida
city: Tampa
country: United States
facility: University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
state: Florida
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy LLC dba Idaho Research
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: Carmel
country: United States
facility: IU North Riley Children's Specialists
state: Indiana
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute Inc.
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy on Broadway
state: Missouri
city: Bellevue
country: United States
facility: Asthma & Allergy Center, PC
state: Nebraska
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai, Clinical Research Unit
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Research of Charlotte
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Baker Allergy Asthma & Dermatology Research Center, LLC
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia: Allergy / Immunology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: Memphis
country: United States
facility: LeBonheur Children's Hospital - Outpatient Building
state: Tennessee
city: Austin
country: United States
facility: Specially for Children Allergy, Asthma and Immunology Clinic
state: Texas
city: Dallas
country: United States
facility: Allergy Partners of North Texas Research
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Northwest Asthma and Allergy Center
state: Washington
city: Hamilton
country: Canada
facility: Ohayon
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research, Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Odense
country: Denmark
facility: Odense Universitetshospital - Department of Dermatology and Allergy Center
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Frankfurt am Main
country: Germany
facility: Medaimun GmbH
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
city: Cork
country: Ireland
facility: Cork University Hospital
city: Padova
country: Italy
facility: Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
city: Groningen
country: Netherlands
facility: Universitair medisch Centrum Groningen
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Stockholm
country: Sweden
facility: Barnforskningscentrum, Sachs' Children and Youth Hospital
city: London
country: United Kingdom
facility: Guy and St Thomas' NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
Study officials:
affiliation: Aimmune Therapeutics, Inc.
name: Director of Regulatory Affairs
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.