ARTEMIS Peanut Allergy In Children (ARTEMIS)
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| ClinicalTrials.gov Identifier: NCT03201003 |
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Recruitment Status :
Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : July 16, 2018
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Sponsor:
Aimmune Therapeutics, Inc.
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.
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Brief Summary:
The purpose of this study is to demonstrate the efficacy and safety of AR101 through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peanut Allergy | Biological: AR101 Other: Placebo | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 175 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS) |
| Actual Study Start Date : | June 12, 2017 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | February 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Biological/Vaccine: AR101
AR101 powder provided in capsules & sachets
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Biological: AR101
AR101 powder |
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Placebo Comparator: Placebo
Placebo powder provided in capsules & sachets
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Other: Placebo
Placebo powder |
Primary Outcome Measures :
- Efficacy of AR101: Proportion of subjects who tolerate specified challenge doses with only AEs of mild severity at the Exit DBPCFC [ Time Frame: 9-14 months ]The proportion of subjects who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit DBPCFC
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| Ages Eligible for Study: | 4 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201003
Locations
| France | |
| Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon | |
| Bordeaux Cedex, France, 33076 | |
| Hopital Saint Vincent de Paul, Service d'Allergologie | |
| Lille Cedex, France, 59020 | |
| Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital | |
| Lille cedex, France, 59037 | |
| Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg | |
| Strasbourg Cedex, France, 67091 | |
| Germany | |
| Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie | |
| Berlin, Germany, 13353 | |
| University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose | |
| Frankfurt am Main, Germany, 60590 | |
| Ireland | |
| UCC Dept. of Paediatrics and Child, Cork University Hospital | |
| Cork, Ireland | |
| National Children's Research Centre, Our Lady's Children's Hospital Crumlin | |
| Dublin, Ireland, D12 V004 | |
| Italy | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35128 | |
| Spain | |
| Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46 | |
| Madrid, Spain, 28007 | |
| H. Infantil Universitario Niño Jesús, Servicio de Alergia | |
| Madrid, Spain, 28009 | |
| Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos | |
| Madrid, Spain, 28040 | |
| Sweden | |
| Sachsska Children and Youth Hospital | |
| Stockholm, Sweden, 118 83 | |
| United Kingdom | |
| James Paget University Hospital | |
| Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA | |
| Guy & St Thomas' Hospital, NHS Foundation Trust | |
| London, United Kingdom, SE1 7EH | |
| St. Mary's Hospital | |
| London, United Kingdom, W2 1NY | |
| Royal Manchester Children's Hospital | |
| Manchester, United Kingdom, M13 9WL | |
| University Hospitals Southampton Foundation NHS Trust | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
| Study Chair: | Kate McKeown | Aimmune Therapeutics |
Additional Information:
| Responsible Party: | Aimmune Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03201003 History of Changes |
| Other Study ID Numbers: |
ARC010 |
| First Posted: | June 28, 2017 Key Record Dates |
| Last Update Posted: | July 16, 2018 |
| Last Verified: | July 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 | |
Keywords provided by Aimmune Therapeutics, Inc.:
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AR101 Characterized Peanut Allergen CPNA (Characterized Peanut Allergen) OIT (oral immunotherapy) Peanut Allergy |
Peanut-Allergic Children Desensitization ARTEMIS Allergy |
Additional relevant MeSH terms:
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Hypersensitivity Peanut Hypersensitivity Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate |