PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

Официальное название

PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis

Обзор

The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).

Подробное описание

Patients with LN will be administered LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab. Additionally, patients will receive treatment with a mycophenolic acid analog (MPAA), specifically mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and oral prednisone (or equivalent).

Вмешательства

• Препарат LUPKYNIS
  voclosporin
• Биопрепарат belimumab, obinutuzumab or anifrolumab
  BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
• Препарат mycophenolic acid analog (MPAA)
  CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])
• Препарат corticosteroid
  prednisone (or equivalent)

Первичные конечные точки

• To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with complete renal response at 24 weeks [Срок оценки: 24 weeks]

Вторичные конечные точки (8)

• To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events [Срок оценки: From baseline to study completion, up to 28 weeks]
• To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with partial renal response at 24 weeks [Срок оценки: 24 weeks]
• To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with deep renal response rate at 24 weeks [Срок оценки: 24 weeks]
• To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response [Срок оценки: From baseline to complete renal response, up to 24 weeks]
• To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to partial renal response [Срок оценки: From baseline to partial renal response, up to 24 weeks]
• To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of anti-double-stranded deoxyribonucleic acid (dsDNA) autoantibodies at 12 weeks and at 24 weeks [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 3 (C3) at 12 weeks and at 24 weeks [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 4 (C4) at 12 weeks and at 24 weeks [Срок оценки: Baseline, 12 weeks, and 24 weeks]

Критерии участия

Критерии включения

• Adults 18-75 years old
• Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V)
• Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and <5.0 g/g from a first morning void (FMV) urine sample
• Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2
• Concomitant biologic:

• Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1.
• Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening.
• Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1
• Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \[or equivalent\]) or by initiating on or before Day 1

Критерии исключения

• Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range
• Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening
• Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \[or equivalent\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening:

• Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)
• Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)
• T cell costimulation modulator (eg, abatacept)
• Intravenous immunoglobulin (IVIg)
• Janus kinase (JAK) inhibitors (eg, upadacitinib)
• Pregnant, breastfeeding or intending to become pregnant during the Study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 27 центров

• Purushotham & Akther Kotha MD, Inc. — La Mesa
• Valerius Medical Group & Research Center of Greater Long Beach, Inc. — Los Alamitos
• Western Nephrology & Metabolic Bone Disease, PC — Arvada
• Swati Shah MD Rheumatology, LLC — Jacksonville
• Vida Clinical Research — Kissimmee
• Life Clinical Trials — Margate
• CTR Oakwater — Orlando
• Parris and Associates Rheumatology — Lawrenceville
• … и ещё 19 центров

Идентификаторы

NCT: NCT07611214 · AUR-VCS-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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