AR101 Real-World Open-Label Extension Study
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|ClinicalTrials.gov Identifier: NCT03337542|
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Biological: AR101||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events [ Time Frame: Approximately 6 months ]
- Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events [ Time Frame: Approximately 6 months ]
- 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 ]
- Number of Participants With Allergic Hypersensitivity Adverse Events [ Time Frame: Approximately 6 months ]
- 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.
- Number of Participants With Epinephrine Use as Rescue Medication [ Time Frame: Approximately 6 months ]
- 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.
- 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).
- 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).
- Number of Participants With Adverse Events That Led to Early Withdrawal [ Time Frame: Approximately 6 months ]
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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:
- 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.
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
|Study Director:||Director of Regulatory Affairs||Aimmune Therapeutics|
Documents provided by Aimmune Therapeutics, Inc.:
|Responsible Party:||Aimmune Therapeutics, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Immune System Diseases
Nut and Peanut Hypersensitivity