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Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden (THALASSA)

2026年9月7日 更新者：Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a double-blind, randomized, placebo-controlled multicenter 2-arm Phase III study, evaluating 300 mg ianalumab s.c. against placebo s.c. in adult participants with Sjögren's disease with high symptom burden.

研究类型

介入性

注册 (估计的)

570

阶段

  • 第三阶段

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

研究联系人备份

  • 姓名：Novartis Pharmaceuticals
  • 电话号码：+41613241111

学习地点

  • 加拿大
    • Quebec
      • Rimouski、Quebec、加拿大、G5L 5T1
        • 招聘中
        • Novartis Investigative Site
  • 澳大利亚
    • Queensland
      • Maroochydore、Queensland、澳大利亚、4558
        • 招聘中
        • Novartis Investigative Site
  • 美国
    • Arizona
      • Peoria、Arizona、美国、85381
        • 招聘中
        • Sun Valley Arthritis Center Ltd
        • 首席研究员：
          • Joy Schechtman
        • 接触：
    • Florida
      • Clearwater、Florida、美国、33765
        • 招聘中
        • Clinical Res Of W Florida
        • 首席研究员：
          • Rodney Daniel
        • 接触：
          • Bridget Ben-Hayon
          • 电话号码：+1 727 466 0078
          • 邮箱：bben@crwf.com
      • Tampa、Florida、美国、33606
        • 招聘中
        • Clinical Research of West Florida Inc
        • 首席研究员：
          • John Carter
        • 接触：
    • Illinois
      • Willowbrook、Illinois、美国、60527
        • 招聘中
        • Willow Rheumatology Wellness
        • 首席研究员：
          • Angela R Crowley
        • 接触：
    • Michigan
      • Saint Clair Shores、Michigan、美国、48081
        • 招聘中
        • Clinical Research Inst of MI
        • 首席研究员：
          • Andrew Sulich
        • 接触：
    • North Carolina
      • Charlotte、North Carolina、美国、28202
        • 招聘中
        • On Site Clinical Solutions Llc
        • 首席研究员：
          • Rakesh C Patel
        • 接触：
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73116
        • 招聘中
        • RAO Research LLC
        • 接触：
        • 首席研究员：
          • John Goetzinger
    • Tennessee
      • Jackson、Tennessee、美国、38305
        • 招聘中
        • West Tennessee Research Institute
        • 首席研究员：
          • Jacob A Aelion
        • 接触：
      • Memphis、Tennessee、美国、38119
        • 招聘中
        • Shelby Research LLC
        • 首席研究员：
          • Ramesh C Gupta
        • 接触：
    • Texas
      • Bellaire、Texas、美国、77401
        • 招聘中
        • Novel Research LLC
        • 首席研究员：
          • Wajeeha Yousaf
        • 接触：
      • Corpus Christi、Texas、美国、78415
        • 招聘中
        • Arthritis Care of Texas
        • 接触：
        • 首席研究员：
          • Eric Ping Chiang
      • Euless、Texas、美国、76040
        • 招聘中
        • Precision Comprehensive Clinical Research Solutions
        • 首席研究员：
          • Renuka Basavaraju
        • 接触：
      • Houston、Texas、美国、77024
        • 招聘中
        • Abigail Neiman MD PA
        • 首席研究员：
          • Abigail Neiman
        • 接触：
      • League City、Texas、美国、77573
      • Leander、Texas、美国、78641
        • 招聘中
        • TEKTON
        • 首席研究员：
          • Paul K Pickrell
        • 接触：
    • Washington
      • Spokane、Washington、美国、99216
        • 招聘中
        • Arthritis Northwest PLLC
        • 首席研究员：
          • Michael C Coan
        • 接触：
  • 韩国
      • Gwangju、韩国、61469
        • 招聘中
        • Novartis Investigative Site

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:

  • Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
  • Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
  • Seropositive for anti-Ro/SSA antibodies at screening
  • SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
  • Screening ESSDAI biologic and/or hematologic domain > 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
  • Stimulated whole salivary flow (sSF) rate > 0.3 mL/min at screening
  • Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.
  • Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.

Exclusion Criteria:

  • Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
  • Systemic sclerosis (SSc)
  • Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.
  • Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
  • Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:
  • 36 weeks prior to randomization, or
  • As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.
  • Prior treatment with ianalumab
  • Prior treatment with any of the following within the given period prior to Screening:
  • Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease
  • Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).
  • History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20).

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：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
药品：VAY736
VAY736 once monthly solution for injection for subcutaneous use.
其他名称：
  • 伊那鲁布
安慰剂比较：Placebo
Placebo once monthly solution for injection for subcutaneous use.
药品：Placebo
Placebo once monthly solution for injection for subcutaneous use.

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
Change from baseline in SSSD oral dryness score
大体时间：Baseline to Week 52
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Baseline to Week 52

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in SSSD summary score
大体时间：Baseline to Week 52
The SSSD summary score is calculated over a defined time window. Each symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Baseline to Week 52
Change from baseline in ESSPRI score
大体时间：Baseline to Week 52
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score is a validated patient-reported outcome assessing three symptom domains: dryness, pain and fatigue. Scores range from 0 (no symptoms) to 10 (worst imaginable symptoms).
Baseline to Week 52
Change from baseline in stimulated whole salivary flow (sSF)
大体时间：Baseline to Week 52
The stimulated whole salivary flow rate, is an objective functional assessment of salivary gland activity, measuring saliva production under stimulation. Higher values indicate better salivary gland function.
Baseline to Week 52
Change from baseline in Patient's Global Assessment (PaGA) NRS score
大体时间：Baseline to Week 52
The Patient's Global Assessment of disease activity captures the patient's overall perception of disease activity. It is assessed using a Numerical Rating Scale (NRS) from 0 to 10. Higher scores indicate worse perceived disease activity.
Baseline to Week 52
Proportion of participants achieving SSSD response
大体时间：Week 52
Proportion of participants achieving a clinically meaningful improvement in the SSSD summary score at Week 52.
Week 52
Proportion of participants achieving ESSPRI response
大体时间：Week 52
Proportion of participants achieving a clinically meaningful improvement in the ESSPRI score at Week 52.
Week 52
Change from baseline in SSSD eye dryness score
大体时间：Baseline to Week 52
The SSSD eye dryness item score is a patient-reported measure assessing severity of eye dryness. The eye dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Baseline to Week 52
Change from baseline in FACIT-Fatigue score
大体时间：Baseline to Week 52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score is a 13-item questionnaire assessing fatigue and its impact on daily activities over the previous 7 days. Higher scores indicate less fatigue / better functioning.
Baseline to Week 52
Change from baseline in Sjögren's-Related Quality of Life (SRQoL) score
大体时间：Baseline to Week 52
The Sjögren's-Related Quality of Life (SRQoL) score is a disease-specific quality-of-life instrument evaluating the impact of Sjögren's disease on physical, emotional, social and daily functioning. Lower scores indicate better quality of life.
Baseline to Week 52

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

Novartis Pharmaceuticals

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7月16日

初级完成 (估计的)

2029年8月14日

研究完成 (估计的)

2033年8月13日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CVAY736A22301
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522271-29-00 (其他标识符：EU CTR)

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

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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