Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using (CPNA) Peanut OIT Safety Follow-On Study

Status:	Completed
Conditions:	Allergy, Allergy
Therapuetic Areas:	Otolaryngology
Healthy:	No
Age Range:	4 - 26
Updated:	2/17/2019
Start Date:	August 2014
End Date:	April 11, 2018

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

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.

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of
Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may
continue Extended Maintenance Phase until CPNA becomes commercially available or the study is
terminated.

Inclusion Criteria:

- Completion of ARC001 study

- Use of birth control for females of child-bearing age

- No change in the status of any longitudinally applicable ARC001 inclusion criteria

Exclusion Criteria:

- 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

We found this trial at

sites

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

(919) 962-2211