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

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AR101 powder provided in capsules & sachets
Placebo powder provided in capsules & sachets
Sponsored by
Aimmune Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring 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

Eligibility Criteria

4 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner University of Arizona Medical Center
  • Arkansas Children's Hospital
  • Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
  • UCLA Medical Center, Santa Monica
  • Allergy & Asthma Associates of Southern California dba Southern California Research
  • Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
  • Peninsula Research Associates, Inc.
  • Allergy & Asthma Medical Group and Research Center, A.P.C
  • Rady Children's Hospital
  • University of California, San Francisco
  • Children's Hospital Colorado
  • Colorado Allergy & Asthma Centers, P.C.
  • National Jewish Health
  • Children's National Medical Center
  • Windom Allergy, Asthma and Sinus
  • University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
  • Atlanta Allergy & Asthma Clinic, PA
  • Idaho Allergy LLC dba Idaho Research
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Comer Children's Hospital
  • Sneeze, Wheeze & Itch Associates, LLC
  • IU North Riley Children's Specialists
  • Chesapeake Clinical Research, Inc.
  • John Hopkins Hospital
  • Massachusetts General Hospital
  • Boston Children's Hospital
  • University of Michigan Health System
  • Clinical Research Institute Inc.
  • Children's Mercy on Broadway
  • Asthma & Allergy Center, PC
  • Atlantic Research Center, LLC
  • Icahn School of Medicine at Mount Sinai, Clinical Research Unit
  • Columbia University Medical Center
  • University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
  • Clinical Research of Charlotte
  • Cincinnati Children's Hospital Medical Center
  • Baker Allergy Asthma & Dermatology Research Center, LLC
  • Children's Hospital of Philadelphia: Allergy / Immunology
  • Children's Hospital of Pittsburgh of UPMC
  • National Allergy and Asthma Research, LLC
  • LeBonheur Children's Hospital - Outpatient Building
  • Specially for Children Allergy, Asthma and Immunology Clinic
  • Allergy Partners of North Texas Research
  • Children's Medical Center
  • Western Sky Medical Research
  • Texas Children's Hospital
  • Sylvana Research
  • Virginia Mason Medical Center
  • Northwest Asthma and Allergy Center
  • Ohayon
  • Cheema Research, Inc.
  • Ottawa Allergy Research Corp
  • Gordon Sussman Clinical Research, Inc.
  • Montreal Children's Hospital
  • Odense Universitetshospital - Department of Dermatology and Allergy Center
  • Charite Universitaetsmedizin Berlin
  • Medaimun GmbH
  • Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
  • Cork University Hospital
  • Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
  • Universitair medisch Centrum Groningen
  • University Medical Center Groningen
  • Hospital General Universitario Gregorio Maranon
  • Hospital Infantil Universitario Nino Jesus
  • Hospital Clinico San Carlos
  • Barnforskningscentrum, Sachs' Children and Youth Hospital
  • Guy and St Thomas' NHS Foundation Trust
  • Central Manchester University Hospitals NHS Foundation Trust
  • University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AR101 powder provided in capsules & sachets

Placebo powder provided in capsules & sachets

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
December 17, 2015
Last Updated
March 16, 2022
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02635776
Brief Title
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Acronym
PALISADE
Official Title
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2015 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
July 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aimmune Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
555 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR101 powder provided in capsules & sachets
Arm Type
Experimental
Arm Description
Study product provided as peanut protein in pull-apart capsules or sachets
Arm Title
Placebo powder provided in capsules & sachets
Arm Type
Placebo Comparator
Arm Description
Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients
Intervention Type
Biological
Intervention Name(s)
AR101 powder provided in capsules & sachets
Intervention Description
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Intervention Type
Biological
Intervention Name(s)
Placebo powder provided in capsules & sachets
Intervention Description
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
12 months
Title
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)
Description
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.
Time Frame
12 months
Title
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)
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Banner University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
UCLA Medical Center, Santa Monica
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California dba Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Peninsula Research Associates, Inc.
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center, A.P.C
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Allergy & Asthma Centers, P.C.
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Windom Allergy, Asthma and Sinus
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic, PA
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Idaho Allergy LLC dba Idaho Research
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
IU North Riley Children's Specialists
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute Inc.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Children's Mercy on Broadway
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Asthma & Allergy Center, PC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Atlantic Research Center, LLC
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Clinical Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Baker Allergy Asthma & Dermatology Research Center, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Children's Hospital of Philadelphia: Allergy / Immunology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
National Allergy and Asthma Research, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
LeBonheur Children's Hospital - Outpatient Building
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Specially for Children Allergy, Asthma and Immunology Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Allergy Partners of North Texas Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sylvana Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Northwest Asthma and Allergy Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Ohayon
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
Cheema Research, Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Ottawa Allergy Research Corp
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Gordon Sussman Clinical Research, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Name
Odense Universitetshospital - Department of Dermatology and Allergy Center
City
Odense
ZIP/Postal Code
DK5000
Country
Denmark
Facility Name
Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medaimun GmbH
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Universitair medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Barnforskningscentrum, Sachs' Children and Youth Hospital
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Guy and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34389504
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.
Results Reference
derived
PubMed Identifier
34320250
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.
Results Reference
derived
PubMed Identifier
30449234
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.
Results Reference
derived

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

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