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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 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1072

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Graz, Austria, 8010
        • Research Site
  • Brasil
      • Salvador, Brasil, 40150-150
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria, 1618
        • Research Site
  • Bélgica
      • Ghent, Bélgica, 9000
        • Research Site
  • Corea del Sur
      • Seoul, Corea del Sur, 6591
        • Research Site
  • Eslovaquia
      • Piešťany, Eslovaquia, 92101
        • Research Site
  • España
      • Barcelona, España, 8041
        • Research Site
      • Granada, España, 18014
        • Research Site
      • Madrid, España, 28034
        • Research Site
      • Madrid, España, 28041
        • Research Site
      • Valencia, España, 46014
        • Research Site
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90045
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33309
        • Research Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Research Site
    • New York
      • New York, New York, Estados Unidos, 10029
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Research Site
  • Filipinas
      • Iloilo City, Filipinas, 5000
        • Research Site
      • Lipa City, Filipinas, 4217
        • Research Site
  • Francia
      • Bordeaux, Francia, 33076
        • Research Site
      • Strasbourg, Francia, 67200
        • Research Site
      • Toulouse, Francia, 31300
        • Research Site
  • Grecia
      • Chaïdári, Grecia, 124 62
        • Research Site
  • India
      • Kolkata, India, 700020
        • Research Site
  • Israel
      • Haifa, Israel, 31048
        • Research Site
  • Italia
      • Milan, Italia, 20122
        • Research Site
  • Japón
      • Sapporo, Japón, 060-8648
        • Research Site
  • Polonia
      • Bydgoszcz, Polonia, 85-168
        • Research Site
      • Kielce, Polonia, 25-316
        • Research Site
      • Krakow, Polonia, 30-040
        • Research Site
  • Reino Unido
      • London, Reino Unido, SE5 9RS
        • Research Site
      • Newcastle upon Tyne, Reino Unido, NE7 7DN
        • Research Site
      • Sheffield, Reino Unido, S10 2JF
        • Research Site
  • Rumania
      • Iași, Rumania, 700661
        • Research Site
  • Serbia
      • Kragujevac, Serbia, 34000
        • Research Site
  • Tailandia
      • Bangkok, Tailandia, 10700
        • Research Site
      • Khon Kaen, Tailandia, 40002
        • Research Site
  • Taiwán
      • Kaohsiung City, Taiwán, 83301
        • Research Site
      • Taichung, Taiwán, 404327
        • Research Site
  • Turquía (Türkiye)
      • Fatih-Istanbul, Turquía (Türkiye), 34098
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Producto combinado: Anifrolumab
Anifrolumab pre-filled syringe
Producto combinado: Anifrolumab
Anifrolumab solution for injection in pre-filled pen
Droga: Anifrolumab
Anifrolumab concentrate for solution for infusion

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
SAEs and Non-Serious AEs
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2032

Finalización del estudio (Estimado)

31 de diciembre de 2032

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2026

Publicado por primera vez (Actual)

9 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D346BC00004

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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