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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03337542
Other study ID # ARC011
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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