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

7. juli 2026 oppdatert av: AstraZeneca

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1072

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Ghent, Belgia, 9000
        • Research Site
  • Brasil
      • Salvador, Brasil, 40150-150
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria, 1618
        • Research Site
  • Filippinene
      • Iloilo City, Filippinene, 5000
        • Research Site
      • Lipa City, Filippinene, 4217
        • Research Site
  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90045
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33309
        • Research Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Research Site
    • New York
      • New York, New York, Forente stater, 10029
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Research Site
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Research Site
      • Strasbourg, Frankrike, 67200
        • Research Site
      • Toulouse, Frankrike, 31300
        • Research Site
  • Hellas
      • Chaïdári, Hellas, 124 62
        • Research Site
  • India
      • Kolkata, India, 700020
        • Research Site
  • Israel
      • Haifa, Israel, 31048
        • Research Site
  • Italia
      • Milan, Italia, 20122
        • Research Site
  • Japan
      • Sapporo, Japan, 060-8648
        • Research Site
  • Polen
      • Bydgoszcz, Polen, 85-168
        • Research Site
      • Kielce, Polen, 25-316
        • Research Site
      • Krakow, Polen, 30-040
        • Research Site
  • Romania
      • Iași, Romania, 700661
        • Research Site
  • Serbia
      • Kragujevac, Serbia, 34000
        • Research Site
  • Slovakia
      • Piešťany, Slovakia, 92101
        • Research Site
  • Spania
      • Barcelona, Spania, 8041
        • Research Site
      • Granada, Spania, 18014
        • Research Site
      • Madrid, Spania, 28034
        • Research Site
      • Madrid, Spania, 28041
        • Research Site
      • Valencia, Spania, 46014
        • Research Site
  • Storbritannia
      • London, Storbritannia, SE5 9RS
        • Research Site
      • Newcastle upon Tyne, Storbritannia, NE7 7DN
        • Research Site
      • Sheffield, Storbritannia, S10 2JF
        • Research Site
  • Sør -Korea
      • Seoul, Sør -Korea, 6591
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Research Site
      • Taichung, Taiwan, 404327
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
  • Tyrkia (Türkiye)
      • Fatih-Istanbul, Tyrkia (Türkiye), 34098
        • Research Site
  • Østerrike
      • Graz, Østerrike, 8036
        • Research Site
      • Graz, Østerrike, 8010
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Anifrolumab
This 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.
Kombinasjonsprodukt: Anifrolumab
Anifrolumab pre-filled syringe
Kombinasjonsprodukt: Anifrolumab
Anifrolumab solution for injection in pre-filled pen
Legemiddel: Anifrolumab
Anifrolumab concentrate for solution for infusion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
SAEs and Non-Serious AEs
Tidsramme: 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
From first dose administered and until 12 weeks after the last dose of Anifrolumab

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. desember 2032

Studiet fullført (Antatt)

31. desember 2032

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D346BC00004

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment. "Yes" indicates that AstraZeneca is accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability commitments in line with EFPIA/PhRMA Data Sharing Principles. For details of timelines, refer to AstraZeneca's disclosure commitment.

Tilgangskriterier for IPD-deling

When a request has been approved, AstraZeneca will provide access to anonymized individual patient-level data via a secure research environment (Vivli). A signed Data Usage Agreement must be in place before accessing the data.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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