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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)

29. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

600

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85012
        • Nábor
        • DM Clinical Research - Phoenix
        • Vrchní vyšetřovatel:
          • Danielle Armas
        • Kontakt:
    • California
      • Northridge, California, Spojené státy, 91324
        • Nábor
        • California Medical Research Associates Inc.
        • Vrchní vyšetřovatel:
          • Jigar Kadakia
        • Kontakt:
    • Colorado
      • Aurora, Colorado, Spojené státy, 80012
        • Nábor
        • Lynn Institute of Denver
        • Vrchní vyšetřovatel:
          • Timothy Colander
        • Kontakt:
    • Florida
      • Leesburg, Florida, Spojené státy, 34748
        • Nábor
        • Clinical Site Partners, LLC Leesburg dba Flourish Research
        • Kontakt:
      • Miami, Florida, Spojené státy, 33135
        • Nábor
        • Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
        • Vrchní vyšetřovatel:
          • Mark Kutner
        • Kontakt:
      • Orange, Florida, Spojené státy, 32763
        • Nábor
        • Optimal Research Sites
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Kristyna Paradis
    • Georgia
      • Rincon, Georgia, Spojené státy, 31326
        • Zatím nenabíráme
        • Centricity Research Columbus
        • Vrchní vyšetřovatel:
          • Maria Mascolo
        • Kontakt:
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46254
        • Nábor
        • DM Clinical Research-Indianapolis
        • Vrchní vyšetřovatel:
          • Brandon Essink
        • Kontakt:
    • Kansas
      • Topeka, Kansas, Spojené státy, 66606
        • Nábor
        • Cotton O'Neil Clinical Research Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Najm Salah
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19107
        • Nábor
        • DM Clinical Research - Philadelphia
        • Kontakt:
        • Vrchní vyšetřovatel:
          • David Wheeler
    • Texas
      • Tomball, Texas, Spojené státy, 77375
        • Nábor
        • DM Clinical Research- Tomball
        • Vrchní vyšetřovatel:
          • Mustafa Naeem
        • Kontakt:
    • Virginia
      • Burke, Virginia, Spojené státy, 22015
        • Nábor
        • Burke Internal Medicine, Inc.
        • Vrchní vyšetřovatel:
          • Nashwa Gabra
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: EXPD-101/FXS7553 Dose 1
Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks.
Lék: EXPD-101/FXS7553 Dose 1
Oral tablet
Experimentální: EXPD-101/FXS7553 Dose 2
Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks.
Lék: EXPD-101/FXS7553 Dose 2
Oral tablet
Komparátor placeba: Placebo
Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks.
Lék: Placebo
EXPD-101/FXS7553 - matching oral tablet.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Annualized rate of moderate and severe COPD exacerbations
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Over 52 weeks
Body weight measured using a calibrated scale at each study visit
Over 52 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to first moderate or severe COPD exacerbation
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Expedition Therapeutics, Inc

Vyšetřovatelé

  • Studijní židle: James Duncan Chalmers, MBChB, PhD, Radcliffe Department of Medicine, University of Oxford

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. června 2026

Primární dokončení (Odhadovaný)

30. června 2028

Dokončení studie (Odhadovaný)

11. července 2028

Termíny zápisu do studia

První předloženo

6. května 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

6. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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