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Completed

NCT Number: NCT03126227

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)

This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster University Medical Center, Hamilton, Ontario, Canada

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About this study

The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Ages 4 to 17 years, inclusive
  • History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
  • Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
  • 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:

  • Subjects in whom the clinical diagnosis of peanut allergy is uncertain
  • Severe or uncontrolled asthma
  • 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

Treatment and study plan

AR101

Biological

AR101 powder provided in capsules

Placebo

Biological

Placebo powder provided in capsules

Primary outcomes

  1. Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events

    Time frame: Approximately 6 months

    Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period.

    Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.

Secondary outcomes

  1. Frequency of Premature Discontinuation of Dosing Due to Adverse Events

    Time frame: Approximately 6 months

  2. Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events

    Time frame: Approximately 6 months

  3. Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing

    Time frame: Approximately 6 months

  4. Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment

    Time frame: Approximately 6 months

  5. Frequency of Anaphylaxis as Defined in the Protocol

    Time frame: Approximately 6 months

    Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:

    • Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence).
    • Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain).
    • Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or > 30% drop in systolic BP; Adults: systolic BP < 90 mm Hg or > 30% drop from their baseline.

  6. Frequency of Epinephrine Use as Rescue Medication

    Time frame: Approximately 6 months

  7. Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods

    Time frame: Approximately 6 months

  8. Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11

    Time frame: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)

    The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control)

  9. Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17

    Time frame: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)

    The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).

  10. Frequency of Adverse Events That Led to Early Withdrawal

    Time frame: Approximately 6 months

Sponsors and collaborators

Lead sponsor

Aimmune Therapeutics, Inc.

Industry

Registry information

Official study title

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)

Acronym: RAMSES

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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