RightFit
RecruitingPhase 3

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

ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study lets people from an earlier benralizumab (Fasenra) study keep getting treatment if the study doctor thinks it will help them. It checks long-term safety and how well people handle the treatment. It is for people who cannot get benralizumab outside the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Finish the required extra treatment period in the earlier study, and have the study doctor agree that continued treatment could help.
  • Follow the earlier study’s birth control rules from the start of this study until 12 weeks after the last dose.
  • If you become able to get pregnant during the study or within 12 weeks after the last dose, agree to start suitable birth control.
  • Need continued benralizumab treatment and be unable to get it outside the study.

Who can't join

  • Have an ongoing side effect that required stopping treatment at the end of the earlier study and that the doctor thinks prevents restarting benralizumab.
  • Plan to get vaccines that contain live or weakened germs.
  • Plan to use biologic medicines, which are made from living cells, including medicines that target immune cells called B cells. An exception is allowed for another health condition with no other medicine available.
  • Have a physical or mental health condition that the study doctor thinks could make joining unsafe or limit your ability to take part.
  • Be in another clinical study at the same time, other than the earlier benralizumab study.
  • Have left the earlier study before finishing the required extra treatment or treatment period.
  • Be able to get benralizumab locally outside the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * 3\. 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. * 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. * 5\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation. Exclusion Criteria: * 1\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab. * 2\. Participants who are planning to use live/live-attenuated vaccines. * 3\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available. * 4\. Participants with any medical condition (such as cancer or viral infections \[hepatitis\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments. * 5\. Concurrently enrolled in any clinical study (other than a parent study). * 6\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period. * 7\. Local access to commercially available benralizumab.

Study sites (8)

CO

MD

MI

NC

NJ

NY

OH

UT