ARTEMIS Peanut Allergy In Children (ARTEMIS)
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ClinicalTrials.gov Identifier: NCT03201003 |
Recruitment Status :
Completed
First Posted : June 28, 2017
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peanut Allergy | Biological: AR101 powder provided in capsules & sachets Other: Placebo powder provided in capsules & sachets | Phase 3 |
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 |
Actual Primary Completion Date : | February 15, 2019 |
Actual Study Completion Date : | February 15, 2019 |
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 |
- 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.
- 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.
- 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.
- 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)

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Ages Eligible for Study: | 4 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Director of Regulatory Affairs | Aimmune Therapeutics |
Documents provided by Aimmune Therapeutics, Inc.:
Responsible Party: | Aimmune Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03201003 |
Other Study ID Numbers: |
ARC010 |
First Posted: | June 28, 2017 Key Record Dates |
Results First Posted: | August 3, 2021 |
Last Update Posted: | August 3, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
AR101 Characterized Peanut Allergen CPNA (Characterized Peanut Allergen) OIT (oral immunotherapy) Peanut Allergy |
Peanut-Allergic Children Desensitization ARTEMIS Allergy |
Hypersensitivity Peanut Hypersensitivity Immune System Diseases |
Nut and Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity, Immediate |