Skip to main content
OpenTrials
Completed

NCT Number: NCT03337542

AR101 Real-World Open-Label Extension Study

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Completed

Looking for future studies?

Notify Me

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

AR101

Biological

AR101

Primary outcomes

  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 outcomes

  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:

    • 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. 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

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, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.