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A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis (SOLUNA)

2026年8月20日 更新者：Hoffmann-La Roche

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

This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

研究联系人备份

  • 姓名：Reference Study ID Number: GA45799 https://forpatients.roche.com/ No attachments to email below.
  • 电话号码：888-662-6728 (U.S. Only)
  • 邮箱：global-roche-genentech-trials@gene.com

学习地点

  • 南非
    • Gauteng
      • Pretoria、Gauteng、南非、0002
        • 招聘中
        • Emmed Research
    • Western Cape
      • Cape Town、Western Cape、南非、7925
        • 招聘中
        • University of Cape Town Kidney and Hypertension Research Unit
      • Somerset West、Western Cape、南非、7130
        • 招聘中
        • Clinical Trials Network Helderberg
  • 哥伦比亚
      • Barranquilla、哥伦比亚、080020
        • 招聘中
        • Clínica de la Costa S.A.S
      • Bogotá、哥伦比亚、110221
        • 招聘中
        • Administradora Country S.A.S.
      • Bogotá、哥伦比亚、110221
        • 招聘中
        • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
      • Medellín、哥伦比亚、050034
        • 招聘中
        • Hospital Pablo Tobon Uribe
  • 墨西哥
    • Coahuila
      • Torreón、Coahuila、墨西哥、27000
        • 招聘中
        • CIMAB S.A. de C.V.
    • Estado de Baja California
      • Mexicali、Estado de Baja California、墨西哥、21100
        • 招聘中
        • Centro Medico del Angel
    • Mexico CITY (federal District)
      • México、Mexico CITY (federal District)、墨西哥、11850
        • 招聘中
        • Centro de Investigación y Tratamiento Reumatológico S.C.
    • Sinaloa
      • Culiacán、Sinaloa、墨西哥、80000
        • 招聘中
        • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
  • 巴西
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、40150-150
        • 招聘中
        • Clnica SER da Bahia
    • Federal District
      • Brasília、Federal District、巴西、70200-730
        • 招聘中
        • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • Mato Grosso
      • Cuiab、Mato Grosso、巴西、78020-500
        • 招聘中
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90480-000
        • 招聘中
        • LMK Servios Mdicos S/S Ltda
    • Rio de Janeiro
      • Niterói、Rio de Janeiro、巴西、24030-103
        • 招聘中
        • Complexo Hospitalar de Niteroi
    • São Paulo
      • Ribeiro Preto、São Paulo、巴西、14048-900
        • 招聘中
        • Hospital das Clinicas de Ribeirao Preto
      • São Paulo、São Paulo、巴西、05403-000
        • 招聘中
        • Hospital das Clnicas da Faculdade de Medicina da USP
  • 意大利
    • Lazio
      • Rome、Lazio、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Brescia、Lombardy、意大利、25123
        • 招聘中
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Rozzano、Lombardy、意大利、20089
        • 招聘中
        • Istituto Clinico Humanitas

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
  • 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
  • Any major episode of infection as defined by the protocol
  • History of serious recurrent or chronic infection
  • History of progressive multifocal leukoencephalopathy (PML)
  • Tuberculosis (TB) infection
  • History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
  • Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening
  • Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable
  • High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions
  • Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex
  • History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1
  • History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years
  • Receipt of any live or attenuated vaccine in the 28 days prior to or during screening

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Mosunetuzumab
Participants will receive mosunetuzumab by subcutaneous (SC) injection.
药品：Mosunetuzumab
Participants will receive SC mosunetuzumab.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants who have achieved remission by Week 76
大体时间：Up to Week 76
Drug-Free Remission is defined as achieving both of the following: Absence of disease activity maintained for 6 months after completion of mosunetuzumab treatment, and; not receiving any SLE-directed therapy (except for antimalarials) during the 6 months. Doses of prednisone (or equivalent) ≤5 mg/day to treat secondary adrenal insufficiency are permitted.
Up to Week 76

次要结果测量

结果测量
措施说明
大体时间
发生不良事件 (AE) 的参与者百分比
大体时间：长达 2.5 年
长达 2.5 年
莫苏奈珠单抗的血清浓度
大体时间：长达2.5年
长达2.5年
Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76
大体时间：Up to Week 76
DORIS remission is defined as achievement of all of the following for at least 6 months: Clinical systemic lupus erythematosus disease activity index (cSLEDAI) = 0 after completion of mosunetuzumab treatment; stable dosing of SLE therapies for at least 6 months; Physician Global Assessment (PGA) of < 0.5, and; prednisone (or equivalent) dose ≤5 mg/day.
Up to Week 76
Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104
大体时间：Weeks 24, 52, 76, and 104
CRR is defined as all of the following: Urinary protein-to-creatinine ratio (UPCR) < 0.5 g/g, and; estimated glomerular filtration rate (eGFR) ≥ 85% of baseline, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or ≥ 60 ml/min per 1.73 m^2 of body-surface area.
Weeks 24, 52, 76, and 104
Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104
大体时间：Weeks 24, 52, 76, and 104
PRR is defined as all of the following: ≥ 50% reduction in UPCR from baseline; UPCR < 1 g/g (or < 3 g/g if the baseline UPCR was ≥ 3 g/g), and; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation.
Weeks 24, 52, 76, and 104
Longitudinal change in titers of anti-double-stranded (ds) DNA
大体时间：Up to 2.5 years
Up to 2.5 years
Longitudinal changes in complement C3 and C4
大体时间：Up to 2.5 years
Up to 2.5 years
Percentage of participants with anti-drug antibodies (ADAs)
大体时间：Baseline up to 2.5 years
Baseline up to 2.5 years
CD19+ absolute counts in blood
大体时间：Up to 2.5 years
Up to 2.5 years
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue
大体时间：Baseline to Week 76
Baseline to Week 76
Change in Subject's Global Assessment of Disease Activity (SGA)
大体时间：Baseline to Week 76
Baseline to Week 76

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

调查人员

  • 研究主任：Clinical Trials、Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月25日

初级完成 (估计的)

2028年2月28日

研究完成 (估计的)

2028年8月31日

研究注册日期

首次提交

2026年2月2日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GA45799
  • 2024-519930-22-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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