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Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

Primary Purpose

Peanut Allergy

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AR101
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, OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, CPNA (Characterized Peanut Allergen)

Eligibility Criteria

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

Key Inclusion Criteria:

  • Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
  • Written informed consent and/or assent from subjects/guardians as appropriate
  • Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

  • Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
  • Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study
  • Discontinued early from the parent study

Sites / Locations

  • Alabama Allergy and Asthma Center
  • Medical Research of Arizona, Allergy, Asthma & Immunology Associates
  • Banner Univ. of Arizona Medical Center
  • Arkansas Children's Hospital
  • Jonathan Corren, M.D., Inc.
  • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
  • Allergy & Asthma Associates of Southern California
  • Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
  • Stanford University
  • Peninsula Research Associates
  • Allergy & Asthma Medical Group and Research Center
  • Rady Children's Hospital, Div. of Allergy & Immunology
  • UCSF, Benioff Children's Hospital - Allergy and Immunology
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
  • UCLA Medical Center, Santa Monica
  • Bay Area Allergy
  • Children's Hospital Colorado
  • Asthma & Allergy Associates
  • National Jewish Health
  • Colorado Allergy & Asthma Centers, P.C.
  • Children's National Health System
  • Sher Allergy Specialists - Center for Cough
  • Allergy Associates of the Palm Beaches
  • Sarasota Clinical Research
  • University of South Florida, Asthma Allergy & Immunology Clinical Research Unit
  • Children's Healthcare of Atlanta
  • Atlanta Allergy & Asthma Clinic
  • Idaho Allergy and Research
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • The University of Chicago Medicine, Comer Children's Hospital
  • Sneeze, Wheeze, & Itch Associates
  • Riley Children's Specialists
  • Deaconess Clinic, Inc.
  • Family Allergy & Asthma Research Institute
  • Chesapeake Clinical Research, Inc.
  • Johns Hopkins Hospital, Pediatric Clinical Research Unit
  • Massachusetts General Hospital
  • Boston Children's Hospital
  • Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
  • Clinical Research Institute Inc.
  • Children's Mercy on Broadway
  • Atlantic Research Center
  • Princeton Center for Clinical Research
  • Northwell Health System
  • Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
  • Univ. of Rochester Medical Center, Golisano Children's Hosp.
  • University of North Carolina at Chapel Hill, Clinical & Translational Research Center
  • Clinical Research of Charlotte
  • Cincinnati Children's Hospital Medical Center
  • Bernstein Clinical Research Center, LLC
  • Oklahoma Institute of Allergy and Asthma Clinical Research
  • Columbia Asthma & Allergy Clinic
  • Baker Allergy, Asthma and Dermatology
  • The Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of UPMC
  • National Allergy and Asthma Research, LLC
  • Le Bonheur Children's Hospital, Outpatient Bldg.
  • Specially for Children Allergy, Asthma and Immunology Clinic
  • Children's Health
  • Western Sky Medical Research
  • Texas Children's Hospital, Baylor College of Medicine
  • Central Texas Health Research
  • Virginia Mason Medical Center
  • ASTHMA, Inc. Clinical Research Center
  • McMaster University Medical Center
  • Triple A Lab
  • Cheema Research Inc.
  • Ottawa Allergy Research Corp
  • Gordon Sussman Clinical Research
  • Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
  • Hopital Saint Vincent de Paul- Service d'Allergologie
  • Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
  • Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
  • Charité Universitaetsmedizin Berlin
  • University of Frankfurt
  • Cork University Hospital, UCC Department of Paediatrics and Child Health
  • National Children's Research Centre, Our Lady's Children's Hospital Crumlin
  • Azienda Ospedaliera di Padova
  • Beatrix Children's Hospital, University Medical Center Groningen
  • University Medical Center Groningen
  • Hospital General Universitario Gregorio Marañón
  • H. Infantil Universitario Niño Jesús, Servicio de Alergia
  • Madrid Hospital Clinico San Carlos, Servicio de Alergia
  • Sachsska Children and Youth Hospital
  • Leicester Royal infirmary
  • James Paget University Hospital
  • Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
  • St Mary's Hospital - Paediatric Research Unit
  • Children's Clinical Research Facility, Royal Manchester Children's Hospital
  • Sheffield Children's Hospital
  • University Hospitals Southampton Foundation NHS Trust
  • Central Manchester University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Pathway 1, 2, 3, 4, 5

Arm Description

Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule).

Outcomes

Primary Outcome Measures

Incidence of adverse events including serious adverse events (Safety and Tolerability)
To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101

Secondary Outcome Measures

Peanut allergy desensitization through extended maintenance dosing of AR101
Proportion of subjects who have completed 3-5 years of AR101 (depending on age group) who tolerate each food challenge dose double-blind, placebo-controlled food challenge (DBPCFC) to a maximum 2000mg peanut protein

Full Information

First Posted
September 21, 2017
Last Updated
February 24, 2022
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03292484
Brief Title
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Official Title
A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

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
No

5. Study Description

Brief Summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Detailed Description
This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

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, OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, CPNA (Characterized Peanut Allergen)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Pathway 1, 2, 3, 4, 5
Arm Type
Experimental
Arm Description
Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule).
Intervention Type
Biological
Intervention Name(s)
AR101
Intervention Description
AR101
Primary Outcome Measure Information:
Title
Incidence of adverse events including serious adverse events (Safety and Tolerability)
Description
To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101
Time Frame
Approximately 10 years
Secondary Outcome Measure Information:
Title
Peanut allergy desensitization through extended maintenance dosing of AR101
Description
Proportion of subjects who have completed 3-5 years of AR101 (depending on age group) who tolerate each food challenge dose double-blind, placebo-controlled food challenge (DBPCFC) to a maximum 2000mg peanut protein
Time Frame
Following 3-5 years of AR101 treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol Written informed consent and/or assent from subjects/guardians as appropriate Use of effective birth control by sexually active female subjects of childbearing potential Key Exclusion Criteria: Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study Discontinued early from the parent study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Vadher
Organizational Affiliation
Director, Clinical Operations
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Allergy and Asthma Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Medical Research of Arizona, Allergy, Asthma & Immunology Associates
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Banner Univ. 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
Jonathan Corren, M.D., Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rady Children's Hospital, Div. of Allergy & Immunology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF, Benioff Children's Hospital - Allergy and Immunology
City
San Francisco
State/Province
California
ZIP/Postal Code
95148
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
UCLA Medical Center, Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Bay Area Allergy
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Asthma & Allergy Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Colorado Allergy & Asthma Centers, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sher Allergy Specialists - Center for Cough
City
Largo
State/Province
Florida
ZIP/Postal Code
33778
Country
United States
Facility Name
Allergy Associates of the Palm Beaches
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Sarasota Clinical Research
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
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Idaho Allergy and 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
60611-2605
Country
United States
Facility Name
The University of Chicago Medicine, Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Riley Children's Specialists
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Family Allergy & Asthma Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Johns Hopkins Hospital, Pediatric Clinical Research Unit
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
Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
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
Atlantic Research Center
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Northwell Health System
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ. of Rochester Medical Center, Golisano Children's Hosp.
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill, Clinical & Translational Research Center
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
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Oklahoma Institute of Allergy and Asthma Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Columbia Asthma & Allergy Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Baker Allergy, Asthma and Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
The Children's Hospital of Philadelphia
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
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Le Bonheur Children's Hospital, Outpatient Bldg.
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
Children's Health
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, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
ASTHMA, Inc. Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115-2024
Country
United States
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Triple A Lab
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
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
City
Bordeaux
State/Province
Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Saint Vincent de Paul- Service d'Allergologie
City
Lille
State/Province
Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
City
Strasbourg
State/Province
Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University of Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Cork University Hospital, UCC Department of Paediatrics and Child Health
City
Cork
ZIP/Postal Code
T12 DC4A
Country
Ireland
Facility Name
National Children's Research Centre, Our Lady's Children's Hospital Crumlin
City
Dublin
ZIP/Postal Code
D12 V004
Country
Ireland
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
Province Of Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
Beatrix Children's Hospital, University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H. Infantil Universitario Niño Jesús, Servicio de Alergia
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Madrid Hospital Clinico San Carlos, Servicio de Alergia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Sachsska Children and Youth Hospital
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Leicester Royal infirmary
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
James Paget University Hospital
City
Gorleston-on-Sea
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St Mary's Hospital - Paediatric Research Unit
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Children's Clinical Research Facility, Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
University Hospitals Southampton Foundation NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Central Manchester University Hospitals
City
Wythenshawe
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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
Links:
URL
https://www.aimmune.com/medical-information-request-form/
Description
Click to request more information about this study.

Learn more about this trial

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

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