Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
juillet 2026
décembre 2029
28 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | JEAN-EMMANUEL KAHN | 02/11/2026 18:00:49 | Contacter | ||
Critères
Tous
- 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.
Exclusion Criteria:
- 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 benralizumab.
- 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 ability to participate in
this study as determined by the Investigator based on protocol required assessments.
- 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.