AR101 Real-World Open-Label Extension Study

Phase 3

Completed

Conditions: Peanut Allergy

Registration Number: NCT03337542

Lead Sponsor: Aimmune Therapeutics, Inc.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 243

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)	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

Name	Time	Method
Number of Participants With of Anaphylaxis as Defined in the Protocol	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.
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	Approximately 6 months
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events	Approximately 6 months
Number of Participants With Allergic Hypersensitivity Adverse Events	Approximately 6 months
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods	Approximately 6 months	Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Number of Participants With Adverse Events That Led to Early Withdrawal	Approximately 6 months
Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events	Approximately 6 months
Number of Participants With Epinephrine Use as Rescue Medication	Approximately 6 months
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	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	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).

Trial Locations

Locations (60): Clinical Research Center of Alabama
🇺🇸
Birmingham, Alabama, United States
Medical Research of Arizona
🇺🇸
Scottsdale, Arizona, United States
Banner University of Arizona Medical Center
🇺🇸
Tucson, Arizona, United States
Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
Jonathan Corren, M.D., Inc.
🇺🇸
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California
🇺🇸
Mission Viejo, California, United States
Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
🇺🇸
Mountain View, California, United States
Peninsula Research Associates
🇺🇸
Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center
🇺🇸
San Diego, California, United States
Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
🇺🇸
San Diego, California, United States
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Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States