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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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

600

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：EXPD-101/FXS7553 Dose 1
Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks.
薬：EXPD-101/FXS7553 Dose 1
Oral tablet
実験的：EXPD-101/FXS7553 Dose 2
Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks.
薬：EXPD-101/FXS7553 Dose 2
Oral tablet
プラセボコンパレーター：Placebo
Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks.
薬：Placebo
EXPD-101/FXS7553 - matching oral tablet.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Annualized rate of moderate and severe COPD exacerbations
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Over 52 weeks
Body weight measured using a calibrated scale at each study visit
Over 52 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to first moderate or severe COPD exacerbation
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Expedition Therapeutics, Inc

捜査官

  • スタディチェア：James Duncan Chalmers, MBChB, PhD、Radcliffe Department of Medicine, University of Oxford

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月30日

一次修了 (推定)

2028年6月30日

研究の完了 (推定)

2028年7月11日

試験登録日

最初に提出

2026年5月6日

QC基準を満たした最初の提出物

2026年6月29日

最初の投稿 (実際)

2026年7月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月5日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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