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RecruitingPhase 3

Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study lets people keep taking anifrolumab (Saphnelo) after finishing an earlier study if the study doctor thinks it still helps them. It checks the safety of continued treatment and how well people handle it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You finished all parts of the earlier study and received at least one dose of anifrolumab in that study.
  • The study doctor thinks the possible benefits of continuing treatment are greater than the risks.
  • You follow the study’s birth control rules during the study and for 16 weeks after your last dose.
  • You can sign a consent form showing that you understand and agree to the study’s rules.
  • You can follow the study’s treatment plan.

Who can't join

  • You have an allergic reaction to any ingredient in anifrolumab.
  • You are pregnant, breastfeeding, or plan to become pregnant during the study.
  • You are in another research study, or were in one too recently. Except for the earlier anifrolumab study, you must wait at least 30 days, or longer based on how long the study drug stays in your body.
  • You still have a health problem from the earlier study that required stopping treatment, and the doctor thinks you cannot restart anifrolumab.
  • You take or have taken medicines banned by the earlier study’s rules, or plan to get a vaccine made with live, weakened germs.
  • You plan to use other treatments, or have a physical or mental health condition, that the study doctor thinks could make it unsafe or hard for you to take part.
  • You left the earlier study before finishing all study visits.
  • You have local access to the approved drug for your condition, with its cost covered, as allowed by local rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (15)

AZ

CA

FL

IL

MI

MN

NC

NE

NY

OH

OR

SC

VA