Asthma study: Benralizumab
Official title Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
ClinicalTrials.gov ID: NCT07444567
What this study is testing
What is Benralizumab?
An investigational injectable medicine being studied for asthma and other conditions. It is designed to target and reduce certain immune cells involved in asthma.
Also referred to as Fasenra.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to watch for any long‑term safety or side‑effect issues with benralizumab after people finish a previous trial.
- Who it's for
- It is for people who have already completed or left a parent study and the investigator thinks they can safely keep taking benralizumab.
- What's involved
- Participants will continue to receive benralizumab and will have regular visits and safety tests to check how the drug affects them over time.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- 1\. Provision of signed and dated written ICF. 2\. Participants completing minimum required OLE period of a parent study and judged by the...
- 3\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks...
- 4\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during...
- 5\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.
You likely can't join if
- 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...
- 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...
- 4\. Participants with any medical condition (such as cancer or viral infections [hepatitis]) or psychiatric condition that, in the opinion of the...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Buenos Aires, Argentina
- Florida, Argentina
- Mar del Plata, Argentina
- Mendoza, Argentina
- Rosario, Argentina
- Brussels, Belgium
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Suresnes, France
- Haifa, Israel
- Incheon, South Korea
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Buenos Aires, Argentina; Florida, Argentina; Mar del Plata, Argentina; Mendoza, Argentina; Rosario, Argentina; Brussels, Belgium and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.