Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Start Date
7/24/2026
Completion Date
12/27/2029
Summary
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.
Detailed Description
This will be an open-label, non-randomised, multicentre, international study for eligible participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment as judged by the Investigator. Any clinical study conducted with benralizumab (Fasenra) for indications such as asthma, EGPA, HES and future indications from additional parent studies, is potentially a parent study. Each participant continuing to receive clinical benefit from benralizumab but with no access to the drug after exiting the parent study must be seen at the Investigator site, offered the opportunity to transition to the ROSY-F. The duration of clinical benefit from study treatment for an individual participant can exceed the duration of a clinical trial. To ensure continued supply of treatment to a participant who, as judged by the Investigator, is still receiving benefit when he/she either completes or exits the parent study or when the parent study closes, a roll-over study is the most universally acceptable mechanism for continuing to provide ongoing study treatment.
Eligibility Criteria
Age Range: 6 years to No maximum
Interventions
Benralizumab
Conditions
Locations
Research Site
Aurora, Colorado 80045
United States
Research Site
Bethesda, Maryland 20892
United States
Research Site
Ann Arbor, Michigan 48105
United States
Research Site
Northfield, New Jersey 08225
United States
Research Site
The Bronx, New York 10459
United States
Research Site
Durham, North Carolina 27705
United States
Research Site
Cleveland, Ohio 44106
United States
Research Site
Salt Lake City, Utah 84107
United States
Research Site
Buenos Aires, C1121ABE
Argentina
Research Site
Florida, B1602DQD
Argentina
Research Site
Lobos, 7240
Argentina
Research Site
Mar del Plata, B7600FYK
Argentina
Research Site
Mendoza, 5500
Argentina
Research Site
Mendoza, M5500
Argentina
Research Site
Rosario, 2000
Argentina
Research Site
Rosario, 2000
Argentina
Research Site
San Juan Bautista, 1888
Argentina
Research Site
Innsbruck, 6020
Austria
Research Site
Brussels, 1070
Belgium
Research Site
Edegem, B-2650
Belgium
Research Site
Calgary, British Columbia T2N 4N1
Canada
Research Site
Hamilton, Ontario L8N 4A6
Canada
Research Site
Toronto, Ontario M5G 1E2
Canada
Research Site
Toronto, Ontario M5G 1X8
Canada
Research Site
Toronto, Ontario M5T 3A9
Canada
Research Site
Bron, 69677
France
Research Site
Marseille, 13915
France
Research Site
Montpellier, 34090
France
Research Site
Nantes, 44093
France
Research Site
Paris, 75014
France
Research Site
Paris, 75018
France
Research Site
Pessac, 33604
France
Research Site
Suresnes, 92151
France
Research Site
Ahmedabad, 380052
India
Research Site
Ajmer, 305001
India
Research Site
Haifa, 34362
Israel
Research Site
Holon, 5822012
Israel
Research Site
Roma, 00165
Italy
Research Site
Rotterdam, 3015 GD
Netherlands
Research Site
Chęciny, 26-060
Poland
Research Site
Gdansk, 80-214
Poland
Research Site
Lodz, 90-153
Poland
Research Site
Lodz, 90-302
Poland
Research Site
Incheon, 400-711
South Korea
Research Site
Istanbul, 34093
Turkey (Türkiye)
Research Site
London, W2 1NY
United Kingdom