A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY STUDY OF AR101 CHARACTERIZED ORAL DESENSITIZATION IMMUNOTHERAPY IN SUBJECTS WHO PARTICIPATED IN A PRIOR AR101 STUDY - Long-term Safety Study of AR101 CODIT™

Aimmune Therapeutics, Inc.0 sites1,100 target enrollmentDecember 1, 2017

ConditionsPeanut Allergy Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Peanut Allergy
Sponsor: Aimmune Therapeutics, Inc.
Enrollment: 1100
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 1, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Aimmune Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all the following criteria to be eligible:
•1\. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future clinical study that identifies ARC008 as a follow\-on study option in the protocol
•2\. Written informed consent from the subject or parent/guardian in accordance with local Institutional Review Board (IRB)/Ethics Committee (EC) guidelines
•3\. Written assent from the subject as required by local IRB/EC guidelines
•4\. Use of effective birth control by sexually active females of childbearing potential
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1060
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 50
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•Subjects who meet any of the following criteria are not eligible:
•1\. Did not complete a minimum of 3 months of AR101 Maintenance in the parent study if subject was assigned to AR101 in that study.
•2\. For subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least the 300 mg single dose (443 mg cumulative) of peanut protein at parent study's exit food challenge
•3\. History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or requiring a change in chronic therapeutic regimen, including autoimmune diseases and malignancies
•4\. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
•5\. Developed a clinically significant change in health status during the parent study that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
•6\. Taking a prohibited medication, as listed in Section 5\.9\.5 of the trial protocol
•7\. Currently participating in any other interventional clinical study other than the Aimmune parent study
•8\. Participation in any peanut immunotherapy clinical study, other than Aimmune\-sponsored AR101 studies (including oral, sublingual, or epicutaneous), within 5 years prior to Screening, except for Aimmune Studies ARC002, ARC004, ARC007, ARC010 and ARC011
•9\. Subject is living in the same household or is a dependent of sponsor employees and/or site staff involved in conducting this study, except for subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010 and ARC011