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To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment (Navigator)

2026年8月5日 更新者：Expedition Therapeutics, Inc

A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants With COPD

This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.

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)

600

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

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85012
        • 招聘中
        • DM Clinical Research - Phoenix
        • 首席研究员：
          • Danielle Armas
        • 接触：
    • California
      • Northridge、California、美国、91324
        • 招聘中
        • California Medical Research Associates Inc.
        • 首席研究员：
          • Jigar Kadakia
        • 接触：
    • Colorado
      • Aurora、Colorado、美国、80012
        • 招聘中
        • Lynn Institute of Denver
        • 首席研究员：
          • Timothy Colander
        • 接触：
    • Florida
      • Altamonte Springs、Florida、美国、32701
        • 招聘中
        • International Clinical Research
        • 接触：
        • 首席研究员：
          • Feldman
      • Crystal River、Florida、美国、34229
        • 招聘中
        • Nature Coast Clinical Research
        • 接触：
        • 首席研究员：
          • Potu
      • Leesburg、Florida、美国、34748
        • 招聘中
        • Clinical Site Partners, LLC Leesburg dba Flourish Research
        • 接触：
      • Miami、Florida、美国、33135
        • 招聘中
        • Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
        • 首席研究员：
          • Mark Kutner
        • 接触：
      • Orange、Florida、美国、32763
        • 招聘中
        • Optimal Research Sites
        • 接触：
        • 首席研究员：
          • Kristyna Paradis
    • Georgia
      • Rincon、Georgia、美国、31326
        • 尚未招聘
        • Centricity Research Columbus
        • 首席研究员：
          • Maria Mascolo
        • 接触：
    • Indiana
      • Indianapolis、Indiana、美国、46254
        • 招聘中
        • DM Clinical Research-Indianapolis
        • 首席研究员：
          • Brandon Essink
        • 接触：
    • Kansas
      • Topeka、Kansas、美国、66606
        • 招聘中
        • Cotton O'Neil Clinical Research Center
        • 接触：
        • 首席研究员：
          • Najm Salah
    • Minnesota
      • Maplewood、Minnesota、美国、55109
    • North Carolina
      • Shelby、North Carolina、美国、28150
        • 招聘中
        • Carolina Research Center, Inc.
        • 首席研究员：
          • Jones
        • 接触：
    • Ohio
      • Columbus、Ohio、美国、43215
        • 招聘中
        • Remington-Davis Research
        • 接触：
        • 首席研究员：
          • Cordasco
    • Pennsylvania
      • DuBois、Pennsylvania、美国、15801
        • 招聘中
        • Clinical Research Associates of Central PA, LLC
        • 接触：
        • 首席研究员：
          • Bansal
      • Philadelphia、Pennsylvania、美国、19107
        • 招聘中
        • DM Clinical Research - Philadelphia
        • 接触：
        • 首席研究员：
          • David Wheeler
    • Texas
      • Cypress、Texas、美国、77429
        • 招聘中
        • Horizon Clinical Research Group.
        • 首席研究员：
          • Dileep Puppala
        • 接触：
      • Tomball、Texas、美国、77375
        • 招聘中
        • DM Clinical Research- Tomball
        • 首席研究员：
          • Mustafa Naeem
        • 接触：
    • Virginia
      • Burke、Virginia、美国、22015
        • 招聘中
        • Burke Internal Medicine, Inc.
        • 首席研究员：
          • Nashwa Gabra
        • 接触：
      • Virginia Beach、Virginia、美国、23456

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. Provided written informed consent for the study
  2. Body mass index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females)
  3. Diagnosis of COPD for at least 1 year
  4. COPD with physician-confirmed diagnosis of chronic bronchitis (persistent, productive cough and sputum for at least 3 months in the past year)
  5. At least 2 moderate or > 1 severe exacerbation within 12 months prior to screening
  6. Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year);

  7. Stable maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per below:

    1. Dual therapy: long-acting beta-2 agonist/muscarinic antagonist (LABA/LAMA) or inhaled corticosteroids (ICS)/LAMA, or ICS/LABA OR
    2. Triple therapy: ICS/LAMA/LABA
  8. Post-BD FEV1/FVC < 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening
  9. COPD Assessment Test (CAT) score ≥ 10 at Screening
  10. If participant is of childbearing potential, must commit to practicing highly effective methods of birth control and not donating eggs during the study and at least 14 days after the last dose.

  11. Male participants commit to the following during the study and for at least 14 days after the last dose:

    1. Practice true sexual abstinence (refrain from heterosexual intercourse)
    2. Use a condom with any female partner of childbearing potential and ensure that the partner uses a highly effective contraceptive method (eg, IUD/IUS, combined hormonal contraception, progestogen-only contraception, or bilateral tubal occlusion).
    3. Be vasectomized (≥ 3 months prior to screening)
    4. Refrain from donating sperm during the Treatment Period and for at least 14 days after the last dose of the IP

Exclusion Criteria:

  1. COPD exacerbation within the 4 weeks prior to randomization.
  2. Clinically important pulmonary disease other than COPD (eg, asthma, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, lung cancer, alpha-1 antitrypsin deficiency, tuberculosis).
  3. Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection.
  4. Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1.
  5. History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection, requiring antibiotics or antiviral medication within 14 days prior to Visit 1.
  6. Evidence of active liver disease (with or without ongoing treatment)
  7. Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) > 450 msec (or QTcF > 480 msec in participants with bundle branch block).
  8. Current or history, within the past year of Visit 1, of substance and/or alcohol abuse.

  9. History of cancer except:

    1. Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1
    2. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1
  10. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during Screening Period, which in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
  11. Known history of allergy or reaction to any component of the investigational product formulation
  12. Current treatment with biologic drugs for COPD (eg, dupilumab, mepolizumab) or use of Therapeutics, biologics within 5 half-lives or 4 months, whichever is longer, from randomization
  13. Current long-term treatment with oxygen therapy > 12 hours per day
  14. Use of immunoglobulin or blood products in 30 days prior to Screening
  15. Received a live attenuated vaccine within 30 days prior to Screening
  16. Participants who are participating in the acute phase of a pulmonary rehabilitation program, i.e. who started rehabilitation < 4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included).
  17. History or active conditions associated with the onset of non-hereditary palmoplantar keratosis:
  18. Have any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study

  19. Has active periodontal disease and are either:

    1. Currently treated by a dentist for this condition or
    2. Expected to have periodontal disease-related procedures within the study period
  20. Are scheduled to have tooth extraction that will occur during the study period

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：EXPD-101/FXS7553 Dose 1
Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks.
药品：EXPD-101/FXS7553 Dose 1
Oral tablet
实验性的：EXPD-101/FXS7553 Dose 2
Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks.
药品：EXPD-101/FXS7553 Dose 2
Oral tablet
安慰剂比较：Placebo
Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks.
药品：Placebo
EXPD-101/FXS7553 - matching oral tablet.

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
Annualized rate of moderate and severe COPD exacerbations
大体时间：Over 52 Weeks

Effect of EXPD-101/FXS7553 compared with placebo on rate of moderate and severe COPD exacerbations.

Moderate COPD exacerbation is defined as acute exacerbations of COPD that require either systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or antibiotics.

Severe COPD exacerbation is defined as acute exacerbation of COPD requiring hospitalization or emergency room / urgent care visit ≥ 24 hours.
Over 52 Weeks
The number of participants experiencing an adverse events (AEs)
大体时间：Over 52 weeks
The number of participants experiencing an AE (an AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) will be presented.
Over 52 weeks
Changes in vital sign parameters
大体时间：Over 52 weeks
Vital signs, including systolic and diastolic BP (mmHg), heart rate (beats per minute), body temperature (°C), and respiratory rate will be listed and summarized.
Over 52 weeks
Changes in electrocardiogram (ECG) parameters
大体时间：Over 52 weeks
ECG (graphical tracing that records the electrical signals of your heartbeat) parameters will be summarized.
Over 52 weeks
Number of Participants with Clinically Significant Changes in Physical Examination Findings
大体时间：Over 52 weeks
Physical examination will be performed at each study visit by a qualified investigator. The following body systems will be assessed: ears, nose, throat, skin, cardiovascular, respiratory, musculoskeletal, and neurological.
Over 52 weeks
Number of participants with clinically significant abnormalities
大体时间：Over 52 weeks
Clinical laboratory assessments including hematology, serum chemistry, and urinalysis will be performed at each study visit.
Over 52 weeks
Changes in Physical Exam Parameters - Body Weight
大体时间：Over 52 weeks
Body weight measured using a calibrated scale at each study visit
Over 52 weeks

次要结果测量

结果测量
措施说明
大体时间
Time to first moderate or severe COPD exacerbation
大体时间：Over 52 Weeks
Effect of EXPD-101/FXS7553 compared with placebo on time to first moderate or severe COPD exacerbation.
Over 52 Weeks
Change From Baseline in Quality of Life Questionnaire - St. George's Respiratory Questionnaire (SGRQ)
大体时间：Baseline, Week 52

The SGRQ is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with Chronic Obstructive Pulmonary Disease (COPD).

It contains 50 items in 2 parts. Part 1 has 8 items for assessing the severity of respiratory symptoms (cough, sputum production, wheeze, breathlessness, and the duration and frequency of attacks of breathlessness or wheeze). Part 2 has 42 items across 2 components (Activity and Impacts) related to daily activities and psychosocial impacts of the participant's respiratory condition. The SGRQ total score is calculated as the sum of scores across symptoms, activity, and effects, with 0 indicating the best possible health status and 100 indicating the worst possible health status. A decrease in 4 units in the total score corresponds to a clinically significant improvement in the quality of life.
Baseline, Week 52
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1) and forced vital capacity (FVC)
大体时间：Baseline, Week 52

FEV1 is used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by a spirometer. Postbronchodilator FEV1 tests included spirometry tests performed after administration of bronchodilator.

FVC is used to assess lung function and is the total volume of air that can be forced out after taking a deep breath as measured by a spirometer.
Baseline, Week 52
Change From Baseline at Week 52 in Quality of Life Questionnaire - Evaluating Respiratory Symptoms (E-RS): COPD
大体时间：Baseline, Week 52

The E-RS:COPD™ scale, a part of the EXACT tool, is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS is an 11-item participant-reported diary to measure respiratory symptom items contained in the 14-item EXACT.

Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity. In addition to the total score, symptom domain scores can be calculated for breathlessness (5 items; score range: 0-17), cough and sputum (3 items; score range: 0-11) and chest symptoms (3 items; score range: 0-12) by summing the responses of items within a respective domain. As with the total score, higher domain scores indicate greater severity.
Baseline, Week 52
Annualized rate of severe COPD exacerbations
大体时间：Over 52 Weeks
Effect of EXPD-101/FXS7553 compared with placebo on rate of severe COPD exacerbations.
Over 52 Weeks
Plasma Concentration and metabolites of EXPD-101/FXS755
大体时间：Pre-dose at baseline, and Weeks 2, 4, 12, 28, 52 and 56.
Pre-dose at baseline, and Weeks 2, 4, 12, 28, 52 and 56.
Change from Baseline in sputum neutrophil elastase (NE) activity
大体时间：Over 52 Weeks
Effect of EXPD-101/FXS7553 compared with placebo on sputum neutrophil elastase (NE) activity.
Over 52 Weeks
Annualized rate of COPD exacerbations requiring Emergency Department visit and/or hospitalization
大体时间：Over 52 Weeks
Effect of EXPD-101/FXS7553 compared with placebo on rate of COPD exacerbations requiring Emergency Department visit and/or hospitalization.
Over 52 Weeks

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

Expedition Therapeutics, Inc

调查人员

  • 学习椅：James Duncan Chalmers, MBChB, PhD、Radcliffe Department of Medicine, University of Oxford

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6月30日

初级完成 (估计的)

2028年6月30日

研究完成 (估计的)

2028年7月11日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年8月7日

上次提交的符合 QC 标准的更新

2026年8月5日

最后验证

2026年8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

  • EXPD-101-201
  • 2026-525216-34 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared externally. Data collected in this study will be used solely for internal analysis and regulatory submission purposes, consistent with participant confidentiality protections and sponsor data governance policies.

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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