Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anifrolumab, Anifrolumab, Anifrolumab.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus. Basic parameters: 5 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, Brazil, Bulgaria +17
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment
Overview
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.
Interventions
- Combination product Anifrolumab
Anifrolumab pre-filled syringe - Combination product Anifrolumab
Anifrolumab solution for injection in pre-filled pen - Drug Anifrolumab
Anifrolumab concentrate for solution for infusion
Primary outcome measures
- SAEs and Non-Serious AEs [Time frame: From first dose administered and until 12 weeks after the last dose of Anifrolumab]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Research Site — Los Angeles
- Research Site — Fort Lauderdale
- Research Site — Chicago
- Research Site — Ann Arbor
- Research Site — New York
- Research Site — Charleston
Spain · 5 centers
- Research Site — Barcelona
- Research Site — Granada
- Research Site — Madrid
- Research Site — Madrid
- Research Site — Valencia
France · 3 centers
- Research Site — Bordeaux
- Research Site — Strasbourg
- Research Site — Toulouse
Poland · 3 centers
- Research Site — Bydgoszcz
- Research Site — Kielce
- Research Site — Krakow
United Kingdom · 3 centers
- Research Site — London
- Research Site — Newcastle upon Tyne
- Research Site — Sheffield
Austria · 2 centers
- Research Site — Graz
- Research Site — Graz
Philippines · 2 centers
- Research Site — Iloilo City
- Research Site — Lipa City
Taiwan · 2 centers
- Research Site — Kaohsiung City
- Research Site — Taichung
Thailand · 2 centers
- Research Site — Bangkok
- Research Site — Khon Kaen
Belgium · 1 center
- Research Site — Ghent
Brazil · 1 center
- Research Site — Salvador
Bulgaria · 1 center
- Research Site — Sofia
Greece · 1 center
- Research Site — Chaïdári
India · 1 center
- Research Site — Kolkata
Israel · 1 center
- Research Site — Haifa
Italy · 1 center
- Research Site — Milan
Japan · 1 center
- Research Site — Sapporo
Romania · 1 center
- Research Site — Iași
Serbia · 1 center
- Research Site — Kragujevac
Slovakia · 1 center
- Research Site — Piešťany
South Korea · 1 center
- Research Site — Seoul
Turkey (Türkiye) · 1 center
- Research Site — Fatih-Istanbul
Identifiers
NCT: NCT07691970 · D346BC00004