Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment

Sponsor
AstraZeneca
Study ID
NCT07444567
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Asthma
  • Eosinophilic Granulomatosis With Polyangiitis (EGPA)
  • Hypereosinophilic Syndrome (HES)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Benralizumab — DRUG
    Accessorized Pre-Filled Syringe (Solution for injection).

Study Details

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.

Key Dates

First listed
Mar 3, 2026
Start date
May 25, 2026
Status verified
Mar 2026
Primary completion
Dec 28, 2029
Completion
Dec 28, 2029

Study Design

Enrollment
230 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Benralizumab arm
    Benralizumab will be administrated as an subcutaneous injection at a frequency in line with that received in the parent study.

Primary Outcome Measure

Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab [ Time Frame: From baseline until 8 weeks after the last dose of benralizumab ]

Central Contacts

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