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 sites950 target enrollmentSeptember 28, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Aimmune Therapeutics, Inc.
Enrollment: 950
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 28, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Aimmune Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•A subject must meet all the following criteria to be eligible:
•1\. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC005, ARC007, ARC010, ARC011, or any future clinical study of that identifies ARC008 as a follow\-on study option in the protocol
•2\. Written informed consent from the subject or guardian/parent (or both parents where required by local authorities) 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: 930
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 20
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•A subject who meets any of the following criteria is 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, except for subjects in ARC004 who did not tolerate the nondaily AR101 dosing regimen, subjects in ARC007 or ARC010, or unless specified otherwise in the parent study
•2\. 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 malignancies occurring within 5 years prior to Screening and clinically active autoimmune diseases
•3\. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
•4\. 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
•5\. Taking a prohibited medication, as listed in Section 5\.9\.5
•6\. Currently participating in any other interventional clinical study other than the Aimmune parent study
•7\. Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study
•8\. Subject is living in the same household or is a dependent of sponsor employee and/or site staff involved in conducting this study, except for subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010, and ARC011
•9\. Currently in the build\-up phase of immunotherapy for any non\-food allergen