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Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)

2026年6月29日 更新者：Steven R. Duncan, MD、University of Alabama at Birmingham

Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)

This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Patients with progressive pulmonary fibrosis, identified at any of nine participating leading U.S. medical centers, will be randomized (by computer) in a 1:1 ratio to either AART or treatment as usual (TAU). Stratification factors for randomization are sex (self-identified) and whether or not patients are taking any IPF-approved medication. Patients will be observed for six (6) months, with observations and assessments made at baseline, 30 days after randomization, and 90 and 180 days after randomization.

Data will be electronically submitted via electronic case report forms (eCRF) to a Data Coordinating Center.

The University of Alabama Medical Center Institutional Review Board (IRB) will be the central IRB for all sites.

Specimens collected will also be used in experimental B-cell studies conducted in the laboratory of the Principal Investigator.

研究类型

介入性

注册 (估计的)

52

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

研究联系人备份

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35216
        • University of Alabama at Birmingham
        • 接触：
        • 接触：
        • 首席研究员：
          • Steven R Duncan, MD
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University
        • 接触：
        • 首席研究员：
          • Anthony Esposito, MD
      • Chicago、Illinois、美国、60153
        • Loyola University
        • 首席研究员：
          • Daniel Dilling, MD
        • 接触：
    • Kansas
      • Kansas City、Kansas、美国、60611
        • University of Kansas
        • 首席研究员：
          • Mark Hamblin, MD
        • 接触：
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina
        • 首席研究员：
          • Sean Callahan, MD
        • 接触：
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University
        • 首席研究员：
          • Ross Summer, MD
        • 接触：
      • Philadelphia、Pennsylvania、美国、19140
      • Pittsburgh、Pennsylvania、美国、60611
        • University of Pittsburgh
        • 接触：
        • 接触：
        • 首席研究员：
          • Dan Kass, MD
    • Utah
      • Salt Lake City、Utah、美国、84132
        • University of Utah
        • 首席研究员：
          • Mary Beth Scholand, MD
        • 接触：

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:

  1. Age between 40-85 years old.
  2. A diagnosis of IPF that fulfills latest ATS/ERS Consensus Criteria.
  3. A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p >10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart.
  4. Ability and willingness to give informed consent (no surrogates) and adhere to requirements.
  5. Have eligibility confirmed by a consensus of trial investigators.
  6. Is not now or has been in experimental regimen for at least 2 weeks (or 5 half-lives of agent) and agrees to not become participants in other experimental regimens (other than solely observational registries) for the duration of their participation in this trial (180 days).
  7. Has been immunized with 2025-2026 COVID-19 vaccine (and later versions as they become available) between 1 and 26 weeks prior to randomization.
  8. IPF duration <10 years, based on the date of definitive diagnosis.
  9. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) >0.70

Exclusion Criteria:

  1. Diagnoses of current infection by clinical or microbial assessments.
  2. Diagnoses of an additional or alternative etiology for lung dysfunction based upon clinical assessment, including sepsis, congestive heart failure, thromboembolism, worsened pulmonary artery hypertension, etc. using routine clinical evaluations under direction of the attending physician.
  3. History or serologic evidence of hepatitis B or C infection. Positive serology for Hepatitis C will not exclude patients if their circulating HC virus RNA test is negative.
  4. Coagulopathy, defined as an INR >1.6, PTT >2x control, fibrinogen <100 mg/dL, or platelet count <50,000 unless these abnormalities can be reversed.
  5. Uncontrolled diabetes or hypertension (systolic BP >160 mm Hg and diastolic BP >100 mm Hg) that would contraindicate use of corticosteroids.
  6. Hemodynamic instability, defined as an inotrope or vasopressor requirement.
  7. History of reactions to blood products, murine-derived products, or prior rituximab use within the last six months.
  8. History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen <10 ng/dl. AART is not known to promote cancer, and these criteria are within current guidelines.
  9. Unwillingness to accept blood product transfusion.
  10. Diagnosis of major comorbidities expected to interfere with study participation.
  11. Treatment for >14 days within the preceding month with >20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immuno-suppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), or with rituximab (or other anti-B-cell biological agents) within the last 6 months.
  12. Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and/or substituted (to obviate hemodynamic lability during TPE).
  13. Fertile women who do not agree to contraception or abstinence. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
  14. An alternative, concordant or historical diagnosis of interstitial lung diseases other than IPF, including idiopathic fibrosis with autoimmune features (IPAF) per clinical domain.1
  15. IgA deficiency, to preclude IVIg reactions.
  16. Listed with the United Network for Organ Sharing (UNOS) for lung transplant at the time of enrollment, to minimize the number of censoring due to very early transplants.
  17. Ongoing suspected or known acute exacerbations of IPF (AE-IPF), defined as new onset (within the last 30 days) of dyspnea with increased hypoxemia or oxygen requirement, and new radiographic infiltrates especially with ground glass opacities (GGO).
  18. Patients taking antifibrotic agents at randomization who have not been on a stable dose for at least 6 weeks: these therapies could be initiated, at the discretion of their attending physicians, at or after the midpoint of their participation in STRIVE II (i.e., three months after randomization).
  19. Patients whose oxygen requirements at rest (per an arterial oxygen saturation [SaO2] >0.92) cannot be met with simple nasal cannula at <10L/min.
  20. Patients who are not expected to survive 180 days or, in the opinion of the local attending physician, have a high likelihood of not tolerating the trial interventions due to underlying comorbidities or frailties.

  21. >10% of whole lung images are emphysematous on High Resolution CT scan

    -

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Autoantibody Reduction Therapy (AART)
Patients will be treated with combination of five (5) therapeutic plasma exchanges, followed by one dose of rituximab and then followed with four infusions of intravenous immunoglobulin (IVIg)
其他：Therapeutic Plasma Exchange
Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
其他名称：
  • 血浆置换术
药品：Rituximab
Infusion of humanized mouse monoclonal antibody with specificity for human CD20
其他名称：
  • ritux
药品：Intravenous immunoglobulin
intravenous infusions of normal human immunoglobulin
其他名称：
  • 免疫球蛋白
有源比较器：Treatment as Usual (TAU)
Patients will continue treatment(s) with optimized approved medications for idiopathic pulmonary fibrosis (IPF)
药品：Treatment as Usual
Continued therapy with conventional, approved, specific IPF medications

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
Forced Vital Capacity (FVC)
大体时间：180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of FVC changes over duration of observations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)

次要结果测量

结果测量
措施说明
大体时间
Supplemental Oxygen Requirements (O2)
大体时间：180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of changing O2 requirements over duration of observations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Six-minute walk distances (6MWD)
大体时间：180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of changes of 6MWD over duration of observations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Durations of progression-free survival
大体时间：180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Intergroup comparisons of number who survive without >5% decrements of FVC as percent of predicted normal values
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Composite outcome measure
大体时间：180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Absolute numbers of acute IPF exacerbations or all cause deaths or unscheduled hospitalizations
180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)

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

University of Alabama at Birmingham

调查人员

  • 首席研究员：Steven R Duncan, MD、University of Alabama at Birmingham

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

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 (估计的)

2026年10月1日

初级完成 (估计的)

2030年9月30日

研究完成 (估计的)

2031年3月31日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年6月24日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6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

  • IRB-300016700
  • PR251064 (其他赠款/资助编号：U.S. Department of Defense)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Any shared data would need to be de-identified, shared only with qualified researchers and otherwise be sanctioned by university regulations.

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

在美国制造并从美国出口的产品

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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