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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)

5 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

600

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85012
        • Recrutement
        • DM Clinical Research - Phoenix
        • Chercheur principal:
          • Danielle Armas
        • Contact:
    • California
      • Northridge, California, États-Unis, 91324
        • Recrutement
        • California Medical Research Associates Inc.
        • Chercheur principal:
          • Jigar Kadakia
        • Contact:
    • Colorado
      • Aurora, Colorado, États-Unis, 80012
        • Recrutement
        • Lynn Institute of Denver
        • Chercheur principal:
          • Timothy Colander
        • Contact:
          • Jessica Kovarna
          • Numéro de téléphone: 303-322-0397
          • E-mail: jmoore@lhsi.net
    • Florida
      • Altamonte Springs, Florida, États-Unis, 32701
        • Recrutement
        • International Clinical Research
        • Contact:
        • Chercheur principal:
          • Feldman
      • Crystal River, Florida, États-Unis, 34229
        • Recrutement
        • Nature Coast Clinical Research
        • Contact:
        • Chercheur principal:
          • Potu
      • Leesburg, Florida, États-Unis, 34748
        • Recrutement
        • Clinical Site Partners, LLC Leesburg dba Flourish Research
        • Contact:
      • Miami, Florida, États-Unis, 33135
        • Recrutement
        • Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
        • Chercheur principal:
          • Mark Kutner
        • Contact:
      • Orange, Florida, États-Unis, 32763
        • Recrutement
        • Optimal Research Sites
        • Contact:
        • Chercheur principal:
          • Kristyna Paradis
    • Georgia
      • Rincon, Georgia, États-Unis, 31326
        • Pas encore de recrutement
        • Centricity Research Columbus
        • Chercheur principal:
          • Maria Mascolo
        • Contact:
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46254
        • Recrutement
        • DM Clinical Research-Indianapolis
        • Chercheur principal:
          • Brandon Essink
        • Contact:
    • Kansas
      • Topeka, Kansas, États-Unis, 66606
        • Recrutement
        • Cotton O'Neil Clinical Research Center
        • Contact:
        • Chercheur principal:
          • Najm Salah
    • Minnesota
      • Maplewood, Minnesota, États-Unis, 55109
    • North Carolina
      • Shelby, North Carolina, États-Unis, 28150
        • Recrutement
        • Carolina Research Center, Inc.
        • Chercheur principal:
          • Jones
        • Contact:
    • Ohio
      • Columbus, Ohio, États-Unis, 43215
        • Recrutement
        • Remington-Davis Research
        • Contact:
        • Chercheur principal:
          • Cordasco
    • Pennsylvania
      • DuBois, Pennsylvania, États-Unis, 15801
        • Recrutement
        • Clinical Research Associates of Central PA, LLC
        • Contact:
        • Chercheur principal:
          • Bansal
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Recrutement
        • DM Clinical Research - Philadelphia
        • Contact:
        • Chercheur principal:
          • David Wheeler
    • Texas
      • Cypress, Texas, États-Unis, 77429
        • Recrutement
        • Horizon Clinical Research Group.
        • Chercheur principal:
          • Dileep Puppala
        • Contact:
      • Tomball, Texas, États-Unis, 77375
        • Recrutement
        • DM Clinical Research- Tomball
        • Chercheur principal:
          • Mustafa Naeem
        • Contact:
    • Virginia
      • Burke, Virginia, États-Unis, 22015
        • Recrutement
        • Burke Internal Medicine, Inc.
        • Chercheur principal:
          • Nashwa Gabra
        • Contact:
      • Virginia Beach, Virginia, États-Unis, 23456

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: EXPD-101/FXS7553 Dose 1
Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks.
Médicament: EXPD-101/FXS7553 Dose 1
Oral tablet
Expérimental: EXPD-101/FXS7553 Dose 2
Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks.
Médicament: EXPD-101/FXS7553 Dose 2
Oral tablet
Comparateur placebo: Placebo
Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks.
Médicament: Placebo
EXPD-101/FXS7553 - matching oral tablet.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Annualized rate of moderate and severe COPD exacerbations
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Over 52 weeks
Body weight measured using a calibrated scale at each study visit
Over 52 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to first moderate or severe COPD exacerbation
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Expedition Therapeutics, Inc

Les enquêteurs

  • Chaise d'étude: James Duncan Chalmers, MBChB, PhD, Radcliffe Department of Medicine, University of Oxford

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 juin 2026

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

11 juillet 2028

Dates d'inscription aux études

Première soumission

6 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 juin 2026

Première publication (Réel)

6 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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