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RecruitingPHASE3INTERVENTIONAL

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

This study is for patients who have already been in a clinical trial using the medicine Benralizumab, known as Fasenra. This medicine is used to treat conditions like asthma, Eosinophilic Granulomatosis with Polyangiitis (EGPA), and Hypereosinophilic Syndrome (HES). If you finished a previous study and your doctor believes Benralizumab is still helping you, this 'roll-over' study allows you to continue receiving the treatment. The main goals are to make sure you keep getting the medicine if it's working for you and for doctors to learn more about its safety and how well it's tolerated over a longer time. This helps ensure patients who benefit can keep accessing their treatment.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
230
Start
24 Jul 2026
Estimated completion
03 Jan 2030

What is this study about?

Imagine you've been part of a trial for a new medicine and it's really helped your health condition, like asthma or EGPA. What happens when that trial ends? This new study, called a 'roll-over' study, is designed to help people in just that situation. It's for patients who previously took part in a study for a medicine called Benralizumab (also known as Fasenra).

If your original trial finished, but you and your doctor agree that Benralizumab is still making a positive difference to your health, this study offers a way for you to keep receiving the treatment. It's important because clinical trials often have a set end date, but a patient's need for an effective medicine doesn't always stop then. This study makes sure that if the medicine is working for you, you can continue to get it, especially if it's not yet widely available through your usual healthcare options.

The main purpose of this roll-over study is twofold: first, to ensure people who are benefiting from Benralizumab can continue their treatment without a break. Second, it allows doctors to collect more information on how safe the medicine is and how well people tolerate it over a longer period. This extra information is really valuable for understanding the long-term effects of the treatment.

Key takeaways

  • This study helps patients continue Benralizumab treatment if it's working for them.
  • It's for people who've already been in a previous Benralizumab clinical trial.
  • Doctors will monitor your health and the medicine's long-term safety.
  • You won't be able to join if you can already get Benralizumab through your usual doctor.
  • Your doctor needs to agree that the treatment is still helping you.

Who may be eligible?

To be considered for this study, you must have completed a previous study for Benralizumab and your study doctor must agree that the treatment is still helping you. You also need to agree to use contraception methods as discussed with the study team, if that applies to you, for the duration of the study and for 12 weeks after your last dose. Importantly, you should not be able to get Benralizumab through your regular doctors or pharmacies right now, but your doctor believes you still need it.

There are also some reasons why you might not be able to join. For example, if you had a serious health problem at the end of your previous study that would make it unsafe to restart Benralizumab. You also cannot plan to have certain types of vaccines (live vaccines) or use other specific biological medicines while in this study, unless there's no other treatment for a health issue. Finally, if you're currently in another clinical study (apart from the original Benralizumab study) or if you left your first study early before completing the main treatment period, you wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Did you complete a previous Benralizumab (Fasenra) study?
  2. Does your study doctor believe Benralizumab is still helping you?
  3. Are you currently unable to get Benralizumab through your regular doctors?
  4. Are you willing to discuss and follow contraception requirements, if applicable?
  5. Are you not planning to use certain vaccines or other specific biological medicines?
Answer every question to see your result.

What does participation involve?

If you join this study, you would continue to receive the Benralizumab treatment that helped you in the previous trial. Your study doctor and nurses would regularly check on your health and the effects of the medicine. This involves scheduled visits where they might take blood samples, ask about your symptoms, and generally monitor how you are doing. The study is 'open-label', meaning both you and your doctor will know you are receiving Benralizumab. It's designed to make sure you keep getting treatment if it's working, so the duration will depend on your individual needs and how long the medicine continues to benefit you, or until the study itself ends.

Potential risks and benefits

The potential benefits of joining this study include continuing to receive a treatment that has already proven helpful for your condition, which could lead to ongoing improvement in your symptoms and quality of life. This also means you wouldn't have a gap in your treatment. As with any medicine, there are potential risks, which will be similar to those you might have experienced or been told about in your previous Benralizumab study. These could include side effects or unexpected reactions. Your doctor will discuss all known risks with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (45)

  • Research Site
    Verified postcode
    Aurora, United States· Not yet recruiting
  • Research Site
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    Bethesda, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Ann Arbor, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Northfield, United States· Not yet recruiting
  • Research Site
    Verified postcode
    The Bronx, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Durham, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Cleveland, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Salt Lake City, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Buenos Aires, Argentina· Not yet recruiting
  • Research Site
    Verified postcode
    Florida, Argentina· Not yet recruiting
  • Research Site
    Verified postcode
    Lobos, Argentina· Not yet recruiting
  • Research Site
    Verified postcode
    Mar del Plata, Argentina· Not yet recruiting

Common questions

What is Benralizumab (Fasenra)?

It's a medicine used to treat conditions like certain types of asthma, EGPA, and HES. It works by targeting specific cells in the body.

Who is this study for?

It's for people who have already been in a Benralizumab clinical trial, and whose doctor believes the medicine is still helping them.

Why is this study important?

It allows patients who are benefiting from Benralizumab to continue their treatment after their original trial ends, and helps doctors gather more information on its long-term safety.

Will I know if I'm getting the real medicine?

Yes, this is an 'open-label' study, meaning you and your doctor will know you are receiving Benralizumab.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and this will not affect your future medical care.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Roll-over Study for Participants Who Have Completed a Previo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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