Roll-over Study for Participants Who Have Completed a Previous Clinical Study with Benralizumab

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1013674

• Contact name

  Henrik Hansson

• Contact email

  henrik.hansson1@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Research 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.
  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.

  Benralizumab will be administered via subcutaneous (SC) injection in one of two formulations: 30 mg/mL (30 mg/APFS) in 1 mL APFS, or 20 mg/mL (10 mg/APFS) in 0.5 mL APFS. Site visits will occur approximately every 12 or 24 weeks. Participants will continue to receive benralizumab until they meet one of the treatment discontinuation criteria, as defined in the protocol. A follow-up visit will take place
  approximately 8 weeks after the last dose of benralizumab. There is no maximum duration for taking benralizumab. Participants should continue to receive benralizumab until they meet any of the study discontinuation criteria outlined in the current protocol

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  26/ES/0037

• Date of REC Opinion

  17 Jun 2026

• REC opinion

  Further Information Favourable Opinion