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

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ClinicalTrials.gov Identifier: NCT03126227
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: AR101 Biological: Placebo Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1 randomization to AR101 or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : September 23, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AR101 Powder Provided in Capsules
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
 Biological: AR101
AR101 powder provided in capsules
Placebo Comparator: Placebo powder
Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.
 Biological: Placebo
Placebo powder provided in capsules


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. 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).
    2. 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).
    3. 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 ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT03126227


Locations
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Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
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Study Chair: Director of Regulatory Affairs Aimmune Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Aimmune Therapeutics, Inc.:
Study Protocol  [PDF] September 27, 2017
Statistical Analysis Plan  [PDF] September 27, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03126227    
Other Study ID Numbers: ARC007
First Posted: April 24, 2017    Key Record Dates
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aimmune Therapeutics, Inc.:
AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
 Peanut-Allergic Children
Desensitization
ARC007
Characterized Oral Desensitization Immunotherapy (CODIT™)
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Hypersensitivity
Immune System Diseases
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate