A MULTICENTER OPEN-LABEL LONG-TERM SAFETY STUDY OF AR101 CHARACTERIZED ORAL DESENSITIZATION IMMUNOTHERAPY IN SUBJECTS WHO PARTICIPATED IN A PRIOR AR101 STUDY
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- STATUS
- Not Recruiting
Summary
ARC008 is an open-label, international, long-term safety extension study for eligible subjects who have participated in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future clinical trial of AR101 that identifies ARC008 as a potential post-study option in the protocol. The rationale for conducting ARC008 is 4-fold: - To allow subjects who received placebo in Aimmune sponsored clinical studies with AR101 to receive active drug product - To allow subjects who received AR101 in Aimmune sponsored clinical studies to continue treatment until commercially available - To assess AR101's safety and tolerability 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.
Description
ARC008 is an open-label, international, long-term safety extension study for eligible subjects who have participated in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future clinical trial of AR101 that identifies ARC008 as a potential post-study option in the protocol. The rationale for conducting ARC008 is 4-fold: - To allow subjects who received placebo in Aimmune sponsored clinical studies with AR101 to receive active drug product - To allow subjects who received AR101 in Aimmune sponsored clinical studies to continue treatment until commercially available - To assess AR101's safety and tolerability 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.
Details
| Age | 100years or below |
|---|---|
| Clinical Study Identifier | TX8491 |
| Last Modified on | 19 February 2024 |
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