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

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт Anifrolumab
  Anifrolumab pre-filled syringe
• Комбинированный продукт Anifrolumab
  Anifrolumab solution for injection in pre-filled pen
• Препарат Anifrolumab
  Anifrolumab concentrate for solution for infusion

Первичные конечные точки

• SAEs and Non-Serious AEs [Срок оценки: From first dose administered and until 12 weeks after the last dose of Anifrolumab]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Research Site — Los Angeles
• Research Site — Fort Lauderdale
• Research Site — Chicago
• Research Site — Ann Arbor
• Research Site — New York
• Research Site — Charleston

Испания · 5 центров

• Research Site — Barcelona
• Research Site — Granada
• Research Site — Madrid
• Research Site — Madrid
• Research Site — Valencia

Франция · 3 центра

• Research Site — Bordeaux
• Research Site — Strasbourg
• Research Site — Toulouse

Польша · 3 центра

• Research Site — Bydgoszcz
• Research Site — Kielce
• Research Site — Krakow

Великобритания · 3 центра

• Research Site — London
• Research Site — Newcastle upon Tyne
• Research Site — Sheffield

Австрия · 2 центра

• Research Site — Graz
• Research Site — Graz

Филиппины · 2 центра

• Research Site — Iloilo City
• Research Site — Lipa City

Тайвань · 2 центра

• Research Site — Kaohsiung City
• Research Site — Taichung

Таиланд · 2 центра

• Research Site — Bangkok
• Research Site — Khon Kaen

Бельгия · 1 центр

• Research Site — Ghent

Бразилия · 1 центр

• Research Site — Salvador

Болгария · 1 центр

• Research Site — Sofia

Греция · 1 центр

• Research Site — Chaïdári

Индия · 1 центр

• Research Site — Kolkata

Израиль · 1 центр

• Research Site — Haifa

Италия · 1 центр

• Research Site — Milan

Япония · 1 центр

• Research Site — Sapporo

Румыния · 1 центр

• Research Site — Iași

Сербия · 1 центр

• Research Site — Kragujevac

Словакия · 1 центр

• Research Site — Piešťany

South Korea · 1 центр

• Research Site — Seoul

Turkey (Türkiye) · 1 центр

• Research Site — Fatih-Istanbul

Идентификаторы

NCT: NCT07691970 · D346BC00004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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