PALISADE Follow-on Study (ARC004)
Peanut Allergy
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, PALISADE
Eligibility Criteria
Key Inclusion Criteria:
- Completion of the ARC003 study
- Written informed consent and/or assent from subjects/guardians as appropriate
- Use of effective birth control by sexually active female subjects of child-bearing potential
Key Exclusion Criteria:
- Early discontinuation from the ARC003 study
- Meets any longitudinally applicable ARC003 study exclusion criteria
- (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
- Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Sites / Locations
- Banner University of Arizona Medical Center
- Arkansas Children's Hospital
- Allergy & Asthma Associates of Southern California
- Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
- Peninsula Research Associates, Inc.
- Allergy & Asthma Medical Group and Research Center, APC
- Rady Children's Hospital, San Diego
- University of California, San Francisco
- UCLA Medical Center, Santa Monica
- Children's Hospital Colorado
- Colorado Allergy & Asthma Centers, P.C.
- National Jewish Health
- Children's National Medical Center
- Sarasota Clinical Research
- University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
- Atlanta Allergy & Asthma Clinic, PA
- Idaho Allergy and Research, dba Idaho Research
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Comer Children's Hospital
- Sneeze, Wheeze, & Itch Associates, LLC
- IU North Riley Children's Specialist
- Chesapeake Clinical Research, Inc.
- Johns Hopkins Hospital
- Massachusetts General Hospital
- Boston Children's Hospital, Div. of Allergy & Immunology
- Michigan Medicine, Michigan Clinical Research Unit
- Clinical Research Institute, Inc.
- Children's Mercy on Broadway
- Nebraska Medical Research Institute Inc.
- Atlantic Research Center, LLC
- Icahn School of Medicine at Mount Sinai, Clinical Research Unit
- University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
- Clinical Research of Charlotte
- Cincinnati Children's Hospital Medical Center
- Baker Allergy, Asthma & Dermatology
- The Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh of UPMC
- National Allergy and Asthma Research, LLC
- Le Bonheur Children's Hospital - Outpatient Building
- 'Specially for Children Allergy, Asthma and Immunology Clinic
- Children's Health
- Western Sky Medical Research
- Texas Children's Hospital, Baylor College of Medicine
- Central Texas Health Research
- Sylvana Research Associates
- Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
- Asthma Inc Clinical Research Center
- Triple A Lab
- Cheema Research Inc.
- Ottawa Allergy Research Corp
- Gordon Sussman Clinical Research, Inc.
- Montreal Children's Hospital
- Charité Universitaetsmedizin Berlin
- University of Frankfurt
- Cork University Hospital
- Azienda Ospedaliera di Padova
- Beatrix Children's Hospital, University Medical Center Groningen
- University Medical Center Groningen
- Hospital Gregorio Marañón
- H. Infantil Universitario Niño Jesús
- Hospital Clinico San Carlos
- Sachsska Children and Youth Hospital
- Guy & St Thomas' NHS foundation Trust
- Central Manchester University Hospitals, NHS Foundation Trust
- Central Manchester University Hospitals, NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Other
Other
Group 1 (Placebo Crossovers)
Group 2 (Active Rollovers)
Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.