Clinical trial NCT03337542: AR101 Real-World Open-Label Extension Study
Official title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peanut Allergy
Keywords: AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Peanut-Allergic Children
Desensitization
Food Allergy
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-09
Enrollment: 243
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Approximately 6 months
Secondary outcomes:
measure: Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
timeFrame: Approximately 6 months
measure: Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
timeFrame: Approximately 6 months
measure: 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
timeFrame: Approximately 6 months
measure: Number of Participants With Allergic Hypersensitivity Adverse Events
timeFrame: Approximately 6 months
measure: Number of Participants With of Anaphylaxis as Defined in the Protocol
timeFrame: Approximately 6 months
measure: Number of Participants With Epinephrine Use as Rescue Medication
timeFrame: Approximately 6 months
measure: Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
timeFrame: Approximately 6 months
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Number of Participants With Adverse Events That Led to Early Withdrawal
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona
state: Arizona
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Jonathan Corren, M.D., Inc.
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Mountain View
country: United States
facility: Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego
state: California
city: San Francisco
country: United States
facility: UCSF, Benioff Children's Hospital - Allergy and Immunology
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
city: Walnut Creek
country: United States
facility: Bay Area Allergy
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers, P.C.
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Largo
country: United States
facility: Sher Allergy Specialists - Center for Cough
state: Florida
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research Windom Allergy, Asthma and Sinus
state: Florida
city: Tampa
country: United States
facility: University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
state: Florida
city: Marietta
country: United States
facility: Atlanta Allergy & Asthma Clinic
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy and Research
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine, Comer Children's Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Pediatric Clinical Research Unit
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Division of Allergy and Clinical Immunology
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy on Broadway
state: Missouri
city: Ocean City
country: United States
facility: Atlantic Research Center
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health System
state: New York
city: Rochester
country: United States
facility: Univ. of Rochester Medical Center, Golisano Children's Hosp.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Research of Charlotte
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
state: Oklahoma
city: Clackamas
country: United States
facility: Columbia Asthma & Allergy Clinic
state: Oregon
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: Austin
country: United States
facility: Specially for Children Allergy, Asthma and Immunology Clinic
state: Texas
city: Dallas
country: United States
facility: Children's Health
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: ASTHMA Inc. Clinical Research Center
state: Washington
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: Hamilton
country: Canada
facility: Triple A Lab / Hamilton Allergy
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research Inc. (CRI)
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research
state: Ontario
Study officials:
affiliation: Aimmune Therapeutics
name: Director of Regulatory Affairs
role: STUDY_DIRECTOR
References:
citation: Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.