Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

Официальное название

An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)

Обзор

The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

Подробное описание

The SIRIUS-LN extension study is an up to 6-year open-label extension study for participants who have completed the treatment periods (blinded Treatment Period-1 and blinded Treatment Period-2) of the SIRIUS-LN core study on double-blind or open-label study treatment.

Investigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required. These up to 6 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. However, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.

Вмешательства

• Препарат Ianalumab
  Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).

Первичные конечные точки

• Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death [Срок оценки: Between Week 144E1 and EOS (up to Week 456)]
• Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study]

Вторичные конечные точки (3)

• Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) [Срок оценки: from Week 144E1 up to Week 456]
• Cohort 2: Ianalumab concentration in serum using a validated ELISA [Срок оценки: from Week 144E1 up to Week 456]
• Cohort 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study]

Критерии участия

Критерии включения

• Signed informed consent prior to participation in the extension study.
• Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Критерии исключения

• Use of prohibited therapies
• Pregnant or nursing (lactating) women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• Novartis Investigative Site — Гуанчжоу
• Novartis Investigative Site — Shantou
• Novartis Investigative Site — Шэньчжэнь
• Novartis Investigative Site — Liuzhou
• Novartis Investigative Site — Ухань
• Novartis Investigative Site — Changchun
• Novartis Investigative Site — Binzhou
• Novartis Investigative Site — Пекин
• … и ещё 4 центра

Бразилия · 4 центра

• Novartis Investigative Site — Vitória
• Novartis Investigative Site — Salvador
• Novartis Investigative Site — Belo Horizonte
• Novartis Investigative Site — Santo André

Таиланд · 4 центра

• Novartis Investigative Site — Songkhla
• Novartis Investigative Site — Bangkok
• Novartis Investigative Site — Bangkok
• Novartis Investigative Site — Chiang Mai

Мексика · 3 центра

• Novartis Investigative Site — León
• Novartis Investigative Site — Oaxaca City
• Novartis Investigative Site — Querétaro

South Korea · 3 центра

• Novartis Investigative Site — Suwon
• Novartis Investigative Site — Seoul
• Novartis Investigative Site — Seoul

Чехия · 2 центра

• Novartis Investigative Site — Olomouc
• Novartis Investigative Site — Prague

Guatemala · 2 центра

• Novartis Investigative Site — Guatemala City
• Novartis Investigative Site — Guatemala City

Малайзия · 2 центра

• Novartis Investigative Site — Kuala Lumpur
• Novartis Investigative Site — Sibu

Сингапур · 2 центра

• Novartis Investigative Site — Singapore
• Novartis Investigative Site — Singapore

США · 1 центр

• Circuit Clinical — Orchard Park

Колумбия · 1 центр

• Novartis Investigative Site — Barranquilla

Гонконг · 1 центр

• Novartis Investigative Site — Tuenmen

Венгрия · 1 центр

• Novartis Investigative Site — Budapest

Румыния · 1 центр

• Novartis Investigative Site — Bucharest

Испания · 1 центр

• Novartis Investigative Site — Barcelona

Тайвань · 1 центр

• Novartis Investigative Site — Taichung

Публикации

• Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772. PMID 40465397

Идентификаторы

NCT: NCT06711887 · CVAY736K12301E1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗