Status:
COMPLETED
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Lead Sponsor:
Aimmune Therapeutics, Inc.
Conditions:
Peanut Allergy
Eligibility:
All Genders
4-26 years
Phase:
PHASE2
Brief Summary
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
Detailed Description
This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who partic...
Eligibility Criteria
Inclusion
- Key
- Completion of ARC001 study
- No change in the status of any longitudinally applicable ARC001 inclusion criteria
- Key
Exclusion
- Early termination from ARC001
- Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
- A lapse in dosing of more than 10 days from completion of ARC001
- Change in the status of any longitudinally applicable ARC001 exclusion criteria
Key Trial Info
Start Date :
August 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02198664
Start Date
August 27 2014
End Date
January 4 2018
Last Update
November 9 2021
Active Locations (8)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
UC San Diego
San Diego, California, United States, 92123
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Mount Sinai Medical Center
New York, New York, United States, 10029