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)
Verified date | October 2021 |
Source | Aimmune Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Aimmune Therapeutics, Inc. |
United States, Canada,
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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