AR101 Real-World Open-Label Extension Study

Aimmune Therapeutics, Inc.243 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

243

Conditions

Peanut Allergy

Interventions

AR101BIOLOGICAL

AR101

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (60)

Outcomes

Primary Outcomes

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

Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)

Time frame: Approximately 6 months

Secondary Outcomes

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

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.

Data from ClinicalTrials.gov

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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

...and 50 more locations

Time frame: Approximately 6 months

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

Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.

Time frame: 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

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).

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)

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

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