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

NCT07691970 — Phase 3, Recruiting, 1072 participants, AstraZeneca

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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

RegistryNCT07691970, acronym ROSY-S
StatusRecruiting
PhasePhase 3
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment1072 (Estimated)
SponsorAstraZeneca (Industry)
ConditionsSystemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
InterventionsAnifrolumab (Combination product, drug)
Datesstart 2026-08-31, primary completion 2032-12-30 (estimated), completion 2032-12-30 (estimated), first posted 2026-07-09, last updated 2026-10-02
Locations128 sites in United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada and 27 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus All trials of Anifrolumab

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
AnifrolumabExperimentalCombination Product: Anifrolumab; Drug: AnifrolumabThis is a single arm open-label study with the primary objective of providing continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment and assessing long-term safety and tolerability of anifrolumab until participant meets one of the study discontinuation criteria.
  • Anifrolumab (Combination product): Anifrolumab pre-filled syringe
  • Anifrolumab (Combination product): Anifrolumab solution for injection in pre-filled pen
  • Anifrolumab (Drug): Anifrolumab concentrate for solution for infusion

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 5 Years to 80 Years

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.

+Locations (128)

FacilityCityCountryStatus
Research SitePhoenix, ArizonaUnited StatesNot yet recruiting
Research SiteLos Angeles, CaliforniaUnited StatesRecruiting
Research SiteSan Francisco, CaliforniaUnited StatesNot yet recruiting
Research SiteBoca Raton, FloridaUnited StatesNot yet recruiting
Research SiteFort Lauderdale, FloridaUnited StatesNot yet recruiting
Research SiteChicago, IllinoisUnited StatesNot yet recruiting
Research SiteAnn Arbor, MichiganUnited StatesNot yet recruiting
Research SiteRochester, MinnesotaUnited StatesNot yet recruiting
Research SiteOmaha, NebraskaUnited StatesNot yet recruiting
Research SiteNew York, New YorkUnited StatesNot yet recruiting
Research SiteCharlotte, North CarolinaUnited StatesNot yet recruiting
Research SiteCleveland, OhioUnited StatesNot yet recruiting
Research SitePortland, OregonUnited StatesNot yet recruiting
Research SiteCharleston, South CarolinaUnited StatesNot yet recruiting
Research SiteRoanoke, VirginiaUnited StatesNot yet recruiting
Research SiteQuilmesArgentinaNot yet recruiting
Research SiteSan MiguelArgentinaNot yet recruiting
Research SiteMelbourneAustraliaNot yet recruiting
Research SiteMitchamAustraliaNot yet recruiting
Research SiteGrazAustriaNot yet recruiting
Research SiteGrazAustriaNot yet recruiting
Research SiteLinzAustriaNot yet recruiting
Research SiteViennaAustriaNot yet recruiting
Research SiteGhentBelgiumNot yet recruiting
Research SiteRio de JaneiroBrazilNot yet recruiting
Research SiteSalvadorBrazilNot yet recruiting
Research SiteSanta EfigêniaBrazilNot yet recruiting
Research SiteSão PauloBrazilNot yet recruiting
Research SitePlovdivBulgariaNot yet recruiting
Research SiteSofiaBulgariaNot yet recruiting
Research SiteSofiaBulgariaNot yet recruiting
Research SiteQuébecCanadaNot yet recruiting
Research SiteSantiagoChileNot yet recruiting
Research SiteBeijingChinaNot yet recruiting
Research SiteChongqingChinaNot yet recruiting
Research SiteGuangzhouChinaNot yet recruiting
Research SiteJinanChinaNot yet recruiting
Research SiteLanzhouChinaNot yet recruiting
Research SiteShanghaiChinaNot yet recruiting
Research SiteShenzhenChinaNot yet recruiting
Research SiteShenzhenChinaNot yet recruiting
Research SiteBogotáColombiaNot yet recruiting
Research SitePragueCzechiaNot yet recruiting
Research SiteBordeauxFranceNot yet recruiting
Research SiteParisFranceNot yet recruiting
Research SiteParisFranceNot yet recruiting
Research SiteStrasbourgFranceNot yet recruiting
Research SiteToulouseFranceNot yet recruiting
Research SiteDresdenGermanyNot yet recruiting
Research SiteEssenGermanyNot yet recruiting
Research SiteKielGermanyNot yet recruiting
Research SiteMainzGermanyNot yet recruiting
Research SiteMarburgGermanyNot yet recruiting
Research SiteTübingenGermanyNot yet recruiting
Research SiteChaïdáriGreeceNot yet recruiting
Research SiteHyderabadIndiaNot yet recruiting
Research SiteKolkataIndiaNot yet recruiting
Research SiteNew DelhiIndiaNot yet recruiting
Research SitePuneIndiaNot yet recruiting
Research SiteHaifaIsraelNot yet recruiting
Research SiteKfar SabaIsraelNot yet recruiting
Research SiteBresciaItalyNot yet recruiting
Research SiteConaItalyNot yet recruiting
Research SiteFlorenceItalyNot yet recruiting
Research SiteMilanItalyNot yet recruiting
Research SiteMilanItalyNot yet recruiting
Research SiteRomaItalyNot yet recruiting
Research SiteRomaItalyNot yet recruiting
Research SiteKanazawaJapanNot yet recruiting
Research SiteMaebashiJapanNot yet recruiting
Research SiteNagoyaJapanNot yet recruiting
Research SiteSapporoJapanNot yet recruiting
Research SiteYokohamaJapanNot yet recruiting
Research SiteGuadalajaraMexicoNot yet recruiting
Research SiteGuadalajaraMexicoNot yet recruiting
Research SiteSan Luis Potosí CityMexicoNot yet recruiting
Research SiteRotterdamNetherlandsNot yet recruiting
Research SiteIloilo CityPhilippinesNot yet recruiting
Research SiteLipa CityPhilippinesNot yet recruiting
Research SiteManilaPhilippinesNot yet recruiting
Research SiteBydgoszczPolandNot yet recruiting
Research SiteKatowicePolandNot yet recruiting
Research SiteKielcePolandNot yet recruiting
Research SiteKrakowPolandNot yet recruiting
Research SiteOssyPolandNot yet recruiting
Research SiteWarsawPolandNot yet recruiting
Research SiteBragaPortugalNot yet recruiting
Research SiteLisbonPortugalNot yet recruiting
Research SitePortoPortugalNot yet recruiting
Research SiteBucharestRomaniaNot yet recruiting
Research SiteCluj-NapocaRomaniaNot yet recruiting
Research SiteIașiRomaniaNot yet recruiting
Research SiteBelgradeSerbiaNot yet recruiting
Research SiteKragujevacSerbiaNot yet recruiting
Research SiteKošiceSlovakiaNot yet recruiting
Research SitePiešťanySlovakiaNot yet recruiting
Research SiteJohannesburgSouth AfricaNot yet recruiting
Research SiteSeoulSouth KoreaNot yet recruiting
Research SiteSeoulSouth KoreaNot yet recruiting
Research SiteSeoulSouth KoreaNot yet recruiting

28 more sites not listed.