AR101 Real-World Open-Label Extension Study

Peanut Allergy Clinical Trial

Official title:

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337542
• Other study ID #: ARC011
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2017
• Est. completion date: September 20, 2019

Study information

• Verified date: October 2021
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101
AR101

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario
Canada	Triple A Lab / Hamilton Allergy	Hamilton	Ontario
Canada	Cheema Research Inc. (CRI)	Mississauga	Ontario
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Gordon Sussman Clinical Research	Toronto	Ontario
United States	University of Michigan Division of Allergy and Clinical Immunology	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Specially for Children Allergy, Asthma and Immunology Clinic	Austin	Texas
United States	Chesapeake Clinical Research, Inc.	Baltimore	Maryland
United States	Johns Hopkins Hospital, Pediatric Clinical Research Unit	Baltimore	Maryland
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill, Clinical & Translational Research Center	Chapel Hill	North Carolina
United States	Clinical Research of Charlotte	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	The University of Chicago Medicine, Comer Children's Hospital	Chicago	Illinois
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Columbia Asthma & Allergy Clinic	Clackamas	Oregon
United States	Asthma & Allergy Associates	Colorado Springs	Colorado
United States	Children's Health	Dallas	Texas
United States	Colorado Allergy & Asthma Centers, P.C.	Denver	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Idaho Allergy and Research	Eagle	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Northwell Health System	Great Neck	New York
United States	Texas Children's Hospital, Baylor College of Medicine	Houston	Texas
United States	Children's Mercy on Broadway	Kansas City	Missouri
United States	Sher Allergy Specialists - Center for Cough	Largo	Florida
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Jonathan Corren, M.D., Inc.	Los Angeles	California
United States	Family Allergy & Asthma Research Institute	Louisville	Kentucky
United States	Atlanta Allergy & Asthma Clinic	Marietta	Georgia
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	Sneeze, Wheeze, & Itch Associates, LLC	Normal	Illinois
United States	National Allergy and Asthma Research, LLC	North Charleston	South Carolina
United States	Allergy Associates of the Palm Beaches	North Palm Beach	Florida
United States	Atlantic Research Center	Ocean City	New Jersey
United States	Oklahoma Institute of Allergy and Asthma Clinical Research, LLC	Oklahoma City	Oklahoma
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Clinical Research Institute, Inc.	Plymouth	Minnesota
United States	Univ. of Rochester Medical Center, Golisano Children's Hosp.	Rochester	New York
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	UCSF, Benioff Children's Hospital - Allergy and Immunology	San Francisco	California
United States	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California
United States	UCLA Medical Center, Santa Monica	Santa Monica	California
United States	Sarasota Clinical Research Windom Allergy, Asthma and Sinus	Sarasota	Florida
United States	Medical Research of Arizona	Scottsdale	Arizona
United States	ASTHMA Inc. Clinical Research Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit	Tampa	Florida
United States	Banner University of Arizona Medical Center	Tucson	Arizona
United States	Bay Area Allergy	Walnut Creek	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Approximately 6 months
Secondary	Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events		Approximately 6 months
Secondary	Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events		Approximately 6 months
Secondary	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
Secondary	Number of Participants With Allergic Hypersensitivity Adverse Events		Approximately 6 months
Secondary	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: 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.	Approximately 6 months
Secondary	Number of Participants With Epinephrine Use as Rescue Medication		Approximately 6 months
Secondary	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.	Approximately 6 months
Secondary	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).	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)
Secondary	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).	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)
Secondary	Number of Participants With Adverse Events That Led to Early Withdrawal		Approximately 6 months