Clinical trial for Asthma
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?
Benralizumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for 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 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.
- 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's taking place
- Aurora, Colorado, United States
- Bethesda, Maryland, United States
- Ann Arbor, Michigan, United States
- Northfield, New Jersey, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Salt Lake City, Utah, United States
- Buenos Aires, Argentina
- Florida, Argentina
- Lobos, Argentina
- Mar del Plata, Argentina
- Mendoza, Argentina
- Rosario, Argentina
- San Juan Bautista, Argentina
- Innsbruck, Austria
- Brussels, Belgium
- Edegem, Belgium
- Calgary, British Columbia, Canada
- Hamilton, Ontario, Canada
+ 20 more site(s).
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 - 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?
Study sites include Aurora, Colorado, United States; Bethesda, Maryland, United States; Ann Arbor, Michigan, United States; Northfield, New Jersey, United States; The Bronx, New York, United States; Durham, North Carolina, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.