Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07444567
Brief Summary:
The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.
Detailed Description:
This will be an open-label, non-randomised, multicentre, international study for eligible participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment as judged by the Investigator. Any clinical study conducted with benralizumab (Fasenra) for indications such as asthma, EGPA, HES and future indications from additional parent studies, is potentially a parent study.
Each participant continuing to receive clinical benefit from benralizumab but with no access to the drug after exiting the parent study must be seen at the Investigator site, offered the opportunity to transition to the ROSY-F. The duration of clinical benefit from study treatment for an individual participant can exceed the duration of a clinical trial. To ensure continued supply of treatment to a participant who, as judged by the Investigator, is still receiving benefit when he/she either completes or exits the parent study or when the parent study closes, a roll-over study is the most universally acceptable mechanism for continuing to provide ongoing study treatment.
Study:
NCT07444567
Study Brief:
Protocol Section:
NCT07444567