Long-term Safety Study of AR101
Research type
Research Study
Full title
A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY STUDY OF AR101 CHARACTERIZED ORAL DESENSITIZATION IMMUNOTHERAPY IN SUBJECTS WHO PARTICIPATED IN A PRIOR AR101 STUDY
IRAS ID
234404
Contact name
George Du Toit
Contact email
Sponsor organisation
Aimmune Therapeutics Inc.
Eudract number
2017-001334-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 31 days
Research summary
The study drug (AR101) is a pharmaceutical grade peanut allergen formulation, which has been shown to have a desensitising effect on patients with known peanut allergy. ARC008 is an open-label, international, long-term safety extension study of AR101, which is only accessible to eligible subjects who have participated in one of Aimmune sponsored 'parent studies' of AR101.
The study has four main objectives:
• To allow participants who received placebo in their parent study the chance to receive the active study drug
• To allow subjects who received active study drug the opportunity to continue treatment
• To further assess the safety and tolerability of the study drug over an extended period of dosing
• To explore whether the level of desensitization to peanut is maintained or even continues to increase after a prolonged duration of dosing.
Subjects will attend a Screening visit, after which they will be assigned to follow one of three treatment pathways. Those patients who tolerated the dosing regimen in their parent study will follow Treatment pathway 1, which consists of an extended maintenance phase within which patients will continue to receive AR101. Those patients who received by failed to tolerate their AR101 dosing regimen will be assigned to Treatment Pathway 2, which consists of a repeat updosing phase, initial maintenance period and extended maintenance. Finally, any patients who received placebo in their parent study will undergo initial escalation, updosing, initial maintenance and extended maintenance in Treatment Pathway 3.
The study duration is not fixed and study participation will continue until either the risk / benefit profile is no longer favourable for the subject in question(as determined by the Investigator), the participant withdraws from the study, the study is discontinued by the Sponsor (either country specific or globally) or AR101 is licenced and becomes available in the UK.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0582
Date of REC Opinion
17 Jan 2018
REC opinion
Further Information Favourable Opinion