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

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

De intervención

Fase

Fase 3

Rango de edad

5 años - 80 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

1072 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

Sin asignación al azar

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (166)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

166 centros

Equipo y fechas

Patrocinador principal

AstraZeneca

Inicio del estudio

31 ago 2026 Real

Finalización primaria

30 dic 2032 Estimado

Finalización del estudio

30 dic 2032 Estimado

Primera publicación

9 jul 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio