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230 Participants NeededMy employer runs this trial

Benralizumab for Asthma

(ROSY-F Trial)

Recruiting at 37 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people who have finished a previous study with benralizumab and are considered by their doctor to still benefit from the treatment. Participants must agree to use contraception if needed, and cannot get benralizumab outside of this study.

Inclusion Criteria

* 4\. 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.
* 1\. Provision of signed and dated written ICF.
2\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.
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What Are the Treatments Tested in This Trial?

Interventions

  • Benralizumab

Trial Overview

The study provides ongoing access to benralizumab for those who benefited in earlier trials, monitoring long-term safety and tolerability. Only participants from prior qualifying studies can join.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Benralizumab armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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