ClinicaliQ Trial Snapshot
- Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07444567.
- Treatment Being Tested: Continued access to benralizumab (Fasenra), a monoclonal antibody targeting IL-5 receptor alpha, for patients with eosinophilic airway diseases who have demonstrated benefit in preceding clinical trials and require ongoing biologic therapy.
- Patient Eligibility Overview: Participants must have completed or exited a parent benralizumab study, shown clinical benefit from treatment, and be deemed appropriate for continuation by their Investigator, with continued monitoring for safety and efficacy outcomes.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 1. Provision of signed and dated written ICF.
- Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment. *
- Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment. *
- Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment. *
- Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.