2024-519930-22-00招募中2 期
A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients with Systemic Lupus Erythematosus with or without Active Lupus Nephritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Achievement of remission by Week 76
研究概览
简要总结
To evaluate the efficacy of mosunetuzumab in conferring remission
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria at screening
- •Agreement to adhere to the contraception requirements
- •Cohort 1 Active Class III and/or Class IV LN per 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) Criteria as confirmed through local laboratory testing of a renal biopsy sample obtained within 3 months of screening, which must meet all of the following criteria: – ≥3 points on the NIH activity index, excluding any contribution from interstitial activity – < 50% glomerulosclerosis and < 50% tubulointerstitial fibrosis – Concomitant Class V disease is permitted – A qualified nephropathologist must verify that participants meet enrollment criteria based on their kidney biopsy. If a qualified nephropathologist is not available at the local site level, a central nephropathologist may evaluate kidney biopsies to verify that the patient has met enrollment criteria.
- •Cohort 1 Participants with biopsy-proven active LN as described above must also meet the following criteria for enrollment: – urinary protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g on a 24-hour urine collection at screening per the central laboratory – C3 complement below the lower limit of normal at screening per the central laboratory – Active LN despite treatment for at least 6 months with standard nonsteroidal LN therapy (e.g. mycophenolate mofetil (MMF), cyclophosphamide, azathioprine, voclosporin, other calcineurin inhibitors, belimumab, rituximab) – Participants previously treated with B-cell-depleting therapy (e.g. rituximab) are eligible to participate as long as the last treatment was given more than 6 months prior
- •Cohort 2 Participants without LN must have autoantibody positivity, hypocomplementemia, and high disease activity at screening despite treatment with advanced therapy
- •Cohort 2 Active disease despite treatment for at least 6 months with either cyclophosphamide or a biologic (e.g., belimumab, anifrolumab, rituximab or other anti-CD20 agent) – Participants previously treated with B cell-depleting therapy (e.g. rituximab) are eligible to participate as long as the last treatment was given more than 6 months prior
排除标准
- •Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required. Participants of childbearing potential must have a negative serum pregnancy test result at screening prior to initiation of study treatment
- •Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study
- •Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration
- •Alcohol or substance abuse within the 12 months prior to screening
- •Active infection of any kind, excluding fungal infection of the nail beds
- •History of progressive multifocal leukoencephalopathy (PML)
结局指标
主要结局
Achievement of remission by Week 76
Achievement of remission by Week 76
次要结局
- Proportion of participants who achieve DORIS by Week 76
- Proportion of participants who achieve CRR at Weeks 52, 76, and 104
- Proportion of participants who achieve PRR at Weeks 52, 76, and 104
- Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) and Cytokine-Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) severity determined according to the 2019 American Society for Transplantation and Cellular Therapy (ASTCT) CRS and ICANS Consensus grading criteria.
- Change from baseline in targeted vital signs
- Change from baseline in targeted clinical laboratory test results
- Longitudinal changes in titers of anti-dsDNA and anti-Smith antibodies
- Longitudinal changes in complement C3 and C4
- Serum concentrations of mosunetuzumab at specified timepoints
- Relevant PK parameters of mosunetuzumab
- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
- B cell levels in the blood (CD19+, absolute counts in blood) at specified timepoints
- Change in Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue from baseline to Week 76
- Change in Subject’s Global Assessment of Disease Activity (SGA) from baseline to Week 76
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (3)
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