Clareo Health | Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Participants are eligible to be included in the study only if all of the following criteria apply:
1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study.
In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants should continue following the contraception requirements as per Appendix B from study enrolment up to 16 weeks after the last dose of study treatment.
Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Capable of adhering to the treatment plan related to this ROSY-S study.
You may not be if
Participant develops hypersensitivity to any of the components of anifrolumab.
Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study.
Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer.
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 anifrolumab.
Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF.
Participants who are planning to use live/live-attenuated vaccines.
Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator.
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.
Participants who discontinued the parent study prior to completion of all study visits.
Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.
