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AR101 Real-World Open-Label Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337542
Recruitment Status : Completed
First Posted : November 9, 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 study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

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

Detailed Description:
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019
Arms and Interventions
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Arm Intervention/treatment
Treatment arm description
Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.
 Biological: AR101
AR101


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Approximately 6 months ]
    Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)


Secondary Outcome Measures :
  1. Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events [ Time Frame: Approximately 6 months ]
  2. Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events [ Time Frame: Approximately 6 months ]
  3. Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing [ Time Frame: Approximately 6 months ]
  4. Number of Participants With Allergic Hypersensitivity Adverse Events [ Time Frame: Approximately 6 months ]
  5. Number of Participants With 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. Number of Participants With Epinephrine Use as Rescue Medication [ Time Frame: Approximately 6 months ]
  7. Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods [ Time Frame: Approximately 6 months ]
    Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.

  8. Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 [ Time Frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) ]
    The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).

  9. Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 [ Time Frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) ]
    The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).

  10. Number of Participants With Adverse Events That Led to Early Withdrawal [ Time Frame: Approximately 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Received AR101 in study ARC007
  • Completed the ARC007 study
  • Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

  • Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
  • Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
  • Currently in the build-up phase of immunotherapy for any nonfood allergen.
  • Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
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): NCT03337542


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

Documents provided by Aimmune Therapeutics, Inc.:
Study Protocol  [PDF] August 20, 2018
Statistical Analysis Plan  [PDF] March 12, 2019

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: NCT03337542    
Other Study ID Numbers: ARC011
First Posted: November 9, 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
Food Allergy
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate