Summary

for people ages 4-26 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

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.

Keywords

Peanut Allergy Characterized Peanut Allergen Peanut OIT Oral Desensitization Peanut Allergen Peanut-Allergic Children Children Peanut-Allergic Adults Peanut Hypersensitivity Peanut protein capsule

Eligibility

You can join if…

Open to people ages 4-26

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego
    San Diego California 92123 United States
  • Children's Medical Center Dallas
    Dallas Texas 75235 United States
  • Arkansas Children's Hospital
    Little Rock Arkansas 72202 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aimmune Therapeutics, Inc.
ID
NCT02198664
Phase
Phase 2
Study Type
Interventional
Last Updated
June 2017