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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 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1072

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Belgien
      • Ghent, Belgien, 9000
        • Research Site
  • Brasilien
      • Salvador, Brasilien, 40150-150
        • Research Site
  • Bulgarien
      • Sofia, Bulgarien, 1618
        • Research Site
  • Filippinerna
      • Iloilo City, Filippinerna, 5000
        • Research Site
      • Lipa City, Filippinerna, 4217
        • Research Site
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Research Site
      • Strasbourg, Frankrike, 67200
        • Research Site
      • Toulouse, Frankrike, 31300
        • Research Site
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90045
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, Förenta staterna, 33309
        • Research Site
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • Research Site
    • New York
      • New York, New York, Förenta staterna, 10029
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Research Site
  • Grekland
      • Chaïdári, Grekland, 124 62
        • Research Site
  • Indien
      • Kolkata, Indien, 700020
        • Research Site
  • Israel
      • Haifa, Israel, 31048
        • Research Site
  • Italien
      • Milan, Italien, 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
  • Rumänien
      • Iași, Rumänien, 700661
        • Research Site
  • Serbien
      • Kragujevac, Serbien, 34000
        • Research Site
  • Slovakien
      • Piešťany, Slovakien, 92101
        • Research Site
  • Spanien
      • Barcelona, Spanien, 8041
        • Research Site
      • Granada, Spanien, 18014
        • Research Site
      • Madrid, Spanien, 28034
        • Research Site
      • Madrid, Spanien, 28041
        • Research Site
      • Valencia, Spanien, 46014
        • Research Site
  • Storbritannien
      • London, Storbritannien, SE5 9RS
        • Research Site
      • Newcastle upon Tyne, Storbritannien, NE7 7DN
        • Research Site
      • Sheffield, Storbritannien, S10 2JF
        • Research Site
  • Sydkorea
      • Seoul, Sydkorea, 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
  • Turkiet (Türkiye)
      • Fatih-Istanbul, Turkiet (Türkiye), 34098
        • Research Site
  • Österrike
      • Graz, Österrike, 8036
        • Research Site
      • Graz, Österrike, 8010
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kombinationsprodukt: Anifrolumab
Anifrolumab pre-filled syringe
Kombinationsprodukt: Anifrolumab
Anifrolumab solution for injection in pre-filled pen
Läkemedel: Anifrolumab
Anifrolumab concentrate for solution for infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SAEs and Non-Serious AEs
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

31 december 2032

Avslutad studie (Beräknad)

31 december 2032

Studieregistreringsdatum

Först inskickad

23 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D346BC00004

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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