Back to resultsARTEMIS Peanut Allergy In Children (ARTEMIS)
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
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARTEMIS, Allergy
Eligibility Criteria
Key Inclusion Criteria:
- Age 4 to 17 years, inclusive
- Clinical history of allergy to peanuts
- Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
- Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
- Written informed consent from the subject's parent/guardian
- Written assent from the subject as appropriate (per local regulatory requirements)
- Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria:
- History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- 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 severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
- 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 a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Sites / Locations
- Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
- Hopital Saint Vincent de Paul, Service d'Allergologie
- Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital
- Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
- Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
- University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose
- UCC Dept. of Paediatrics and Child, Cork University Hospital
- National Children's Research Centre, Our Lady's Children's Hospital Crumlin
- Azienda Ospedaliera di Padova
- Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46
- H. Infantil Universitario Niño Jesús, Servicio de Alergia
- Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos
- Sachsska Children and Youth Hospital
- James Paget University Hospital
- Guy & St Thomas' Hospital, NHS Foundation Trust
- St. Mary's Hospital
- Royal Manchester Children's Hospital
- University Hospitals Southampton Foundation NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
AR101
Placebo
Arm Description
AR101 powder provided in capsules & sachets
Placebo powder provided in capsules & sachets
Outcomes
Primary Outcome Measures
The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
The proportion 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
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge
The proportion 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.
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.
The proportion 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.
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
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
NCT ID
NCT03201003
First Posted
June 22, 2017
Last Updated
July 13, 2021
Sponsor
Aimmune Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03201003
Brief Title
ARTEMIS Peanut Allergy In Children
Acronym
ARTEMIS
Official Title
AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
Detailed Description
This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.
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, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARTEMIS, Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AR101
Arm Type
Active Comparator
Arm Description
AR101 powder provided in capsules & sachets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder provided in capsules & sachets
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
Other
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
The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
Description
The proportion 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
Approximately 9 months
Secondary Outcome Measure Information:
Title
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge
Description
The proportion 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
Approximately 9 months
Title
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.
Description
The proportion 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
Approximately 9 months
Title
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
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
Approximately 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Age 4 to 17 years, inclusive
Clinical history of allergy to peanuts
Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
Written informed consent from the subject's parent/guardian
Written assent from the subject as appropriate (per local regulatory requirements)
Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria:
History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
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 severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
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 a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Saint Vincent de Paul, Service d'Allergologie
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
UCC Dept. of Paediatrics and Child, Cork University Hospital
City
Cork
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
ZIP/Postal Code
35128
Country
Italy
Facility Name
Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46
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
Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos
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
James Paget University Hospital
City
Gorleston-on-Sea
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Guy & St Thomas' Hospital, NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
University Hospitals Southampton Foundation NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
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
32702315
Citation
O'B Hourihane J, Beyer K, Abbas A, Fernandez-Rivas M, Turner PJ, Blumchen K, Nilsson C, Ibanez MD, Deschildre A, Muraro A, Sharma V, Erlewyn-Lajeunesse M, Zubeldia JM, De Blay F, Sauvage CD, Byrne A, Chapman J, Boralevi F, DunnGalvin A, O'Neill C, Norval D, Vereda A, Skeel B, Adelman DC, du Toit G. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020 Oct;4(10):728-739. doi: 10.1016/S2352-4642(20)30234-0. Epub 2020 Jul 20.
Results Reference
derived
Learn more about this trial
ARTEMIS Peanut Allergy In Children
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