Long-term Safety Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

  • Interventional
  • Recruiting
  • NCT03292484
Eligibility Details Visit Clinicaltrials.gov

A Multicenter, Open-label, Long-term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

The purpose of this study is to assess AR101's safety and tolerability over an extended dosing period.

This study is enrolling participants by invitation only. This is an open-label, international, long-term safety extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

Gender
All

Age Group
4 Years to 55 Years

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol

         - Written informed consent and/or assent from subjects/guardians as appropriate

         - Use of effective birth control by sexually active female subjects of childbearing potential

        Key Exclusion Criteria:

         - Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study

         - Early discontinuation from the parent study

         - Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless specified in the parent study

At a Glance

National Government IDNCT03292484

IRB#IRB18-0055

Lead SponsorAimmune Therapeutics, Inc.

Lead PhysicianChristina Ciaccio

Collaborator(s)N/A

EligibilityAll
4 Years to 55 Years
Recruiting