Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Investigational drug(s) / intervention(s)
AnifrolumabAnifrolumabAnifrolumab
Anifrolumab: Anifrolumab pre-filled syringe
Anifrolumab: Anifrolumab solution for injection in pre-filled pen
Anifrolumab: Anifrolumab concentrate for solution for infusion
Study summary
The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.
Study details include:
* Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
* The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
* The participants will continue to receive anifrolumab the same way they received it in the parent trial
* A participant is considered to have completed the study when they meet one of the discontinuation criteria.
* Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.
Eligibility
Sex
ALL
Min age
5 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
SAEs and Non-Serious AEs — From first dose administered and until 12 weeks after the last dose of Anifrolumab Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab
Trial sites (41)
Facility
City
Region
Status
Research Site
Los Angeles
California
Research Site
Fort Lauderdale
Florida
Research Site
Chicago
Illinois
Research Site
Ann Arbor
Michigan
Research Site
New York
New York
Research Site
Charleston
South Carolina
Research Site
Graz
Austria
Research Site
Graz
Austria
Research Site
Ghent
Belgium
Research Site
Salvador
Brazil
Research Site
Sofia
Bulgaria
Research Site
Bordeaux
France
Research Site
Strasbourg
France
Research Site
Toulouse
France
Research Site
Chaïdári
Greece
Research Site
Kolkata
India
Research Site
Haifa
Israel
Research Site
Milan
Italy
Research Site
Sapporo
Japan
Research Site
Iloilo City
Philippines
Research Site
Lipa City
Philippines
Research Site
Bydgoszcz
Poland
Research Site
Kielce
Poland
Research Site
Krakow
Poland
Research Site
Iași
Romania
Research Site
Kragujevac
Serbia
Research Site
Piešťany
Slovakia
Research Site
Seoul
South Korea
Research Site
Barcelona
Spain
Research Site
Granada
Spain
Research Site
Madrid
Spain
Research Site
Madrid
Spain
Research Site
Valencia
Spain
Research Site
Kaohsiung City
Taiwan
Research Site
Taichung
Taiwan
Research Site
Bangkok
Thailand
Research Site
Khon Kaen
Thailand
Research Site
Fatih-Istanbul
Turkey (Türkiye)
Research Site
London
United Kingdom
Research Site
Newcastle upon Tyne
United Kingdom
+ 1 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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