FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

ARTEMIS Peanut Allergy In Children

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 4 Years - 17 Years
Gender All
More Inclusion & Exclusion 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 at or before 444 mg cumulative peanut protein at the Screening DBPCFC - 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 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03201003

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Aimmune Therapeutics, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Kate McKeown
Principal Investigator Affiliation Aimmune Therapeutics

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Active, not recruiting
Countries France, Germany, Ireland, Italy, Spain, Sweden, United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Peanut Allergy
Study Website: View Trial Website
Additional Details

This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bordeaux Cedex, France

Status

Address

Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon

Bordeaux Cedex, , 33076

Lille Cedex, France

Status

Address

Hopital Saint Vincent de Paul, Service d'Allergologie

Lille Cedex, , 59020

Lille cedex, France

Status

Address

Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital

Lille cedex, , 59037

Strasbourg Cedex, France

Status

Address

Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

Strasbourg Cedex, , 67091

Berlin, Germany

Status

Address

Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie

Berlin, , 13353

Frankfurt am Main, Germany

Status

Address

University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose

Frankfurt am Main, , 60590

Cork, Ireland

Status

Address

UCC Dept. of Paediatrics and Child, Cork University Hospital

Cork, ,

Dublin, Ireland

Status

Address

National Children's Research Centre, Our Lady's Children's Hospital Crumlin

Dublin, , D12 V004

Azienda Ospedaliera di Padova, Padova, Italy

Status

Address

Azienda Ospedaliera di Padova

Padova, , 35128

Madrid, Spain

Status

Address

Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46

Madrid, , 28007

Madrid, Spain

Status

Address

H. Infantil Universitario Niño Jesús, Servicio de Alergia

Madrid, , 28009

Madrid, Spain

Status

Address

Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos

Madrid, , 28040

Sachsska Children and Youth Hospital, Stockholm, Sweden

Status

Address

Sachsska Children and Youth Hospital

Stockholm, , 118 83

James Paget University Hospital, Gorleston-on-Sea, Norfolk, United Kingdom

Status

Address

James Paget University Hospital

Gorleston-on-Sea, Norfolk, NR31 6LA

London, United Kingdom

Status

Address

Guy & St Thomas' Hospital, NHS Foundation Trust

London, , SE1 7EH

St. Mary's Hospital, London, United Kingdom

Status

Address

St. Mary's Hospital

London, , W2 1NY

Royal Manchester Children's Hospital, Manchester, United Kingdom

Status

Address

Royal Manchester Children's Hospital

Manchester, , M13 9WL

Southampton, United Kingdom

Status

Address

University Hospitals Southampton Foundation NHS Trust

Southampton, , SO16 6YD

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