AR101 Real-World Open-Label Extension Study
Recruiting in Palo Alto (17 mi)
+59 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Aimmune Therapeutics, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Research Team
Do
Director of Regulatory Affairs
Principal Investigator
Aimmune Therapeutics
Eligibility Criteria
Inclusion Criteria
Received AR101 in study ARC007
Completed the ARC007 study
Use of effective birth control by sexually active female subjects of childbearing potential
See 1 more
Treatment Details
Interventions
- AR101 (Allergen-Specific Immunotherapy)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment arm descriptionExperimental Treatment1 Intervention
Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Colorado Allergy & Asthma Centers, P.C.Denver, CO
Sarasota Clinical Research Windom Allergy, Asthma and SinusSarasota, FL
Idaho Allergy and ResearchEagle, ID
Sneeze, Wheeze, & Itch Associates, LLCNormal, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Aimmune Therapeutics, Inc.
Lead Sponsor
Trials
12
Patients Recruited
3,200+