ARTEMIS Peanut Allergy In Children (ARTEMIS)

July 13, 2021 updated by: Aimmune Therapeutics, Inc.

AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)

The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux Cedex, France, 33076
        • Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon
      • Lille Cedex, France, 59020
        • Hopital Saint Vincent de Paul, Service d'Allergologie
      • Lille cedex, France, 59037
        • Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital
      • Strasbourg Cedex, France, 67091
        • Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
      • Frankfurt am Main, Germany, 60590
        • University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose
  • Ireland
      • Cork, Ireland
        • UCC Dept. of Paediatrics and Child, Cork University Hospital
      • Dublin, Ireland, D12 V004
        • National Children's Research Centre, Our Lady's Children's Hospital Crumlin
  • Italy
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46
      • Madrid, Spain, 28009
        • H. Infantil Universitario Niño Jesús, Servicio de Alergia
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos
  • Sweden
      • Stockholm, Sweden, 118 83
        • Sachsska Children and Youth Hospital
  • United Kingdom
      • London, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • London, United Kingdom, SE1 7EH
        • Guy & St Thomas' Hospital, NHS Foundation Trust
      • Manchester, United Kingdom, M13 9WL
        • Royal Manchester Children's Hospital
      • Southampton, United Kingdom, SO16 6YD
        • University Hospitals Southampton Foundation NHS Trust
    • Norfolk
      • Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA
        • James Paget University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AR101
AR101 powder provided in capsules & sachets
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_COMPARATOR: Placebo
Placebo powder provided in capsules & sachets
Other: Placebo powder provided in capsules & sachets
Study product formulated to contain only inactive ingredients for use as defined in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
Time Frame: Approximately 9 months
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.
Approximately 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge
Time Frame: Approximately 9 months
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.
Approximately 9 months
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.
Time Frame: Approximately 9 months
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.
Approximately 9 months
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
Time Frame: Approximately 9 months
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)
Approximately 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aimmune Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2017

Primary Completion (ACTUAL)

February 15, 2019

Study Completion (ACTUAL)

February 15, 2019

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (ACTUAL)

June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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