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

NCT07684820 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: EXPD-101-2012026-525216-34
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Bronchitis; DPP; DPP1; DPP Inhibitor; DPP1 Inhibitor

Outcome Measures

Primary Outcomes (7)

• Annualized rate of moderate and severe COPD exacerbations

  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)

  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

  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

  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

  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

  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

  Body weight measured using a calibrated scale at each study visit

  Over 52 weeks

Secondary Outcomes (8)

• 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)

  Baseline, Week 52

• Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1) and forced vital capacity (FVC)

  Baseline, Week 52

• Change From Baseline at Week 52 in Quality of Life Questionnaire - Evaluating Respiratory Symptoms (E-RS): COPD

  Baseline, Week 52

• Annualized rate of severe COPD exacerbations

  Over 52 Weeks

Study Arms (3)

EXPD-101/FXS7553 Dose 1

EXPERIMENTAL

Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks.

Drug: EXPD-101/FXS7553 Dose 1

EXPD-101/FXS7553 Dose 2

EXPERIMENTAL

Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks.

Drug: EXPD-101/FXS7553 Dose 2

Placebo

PLACEBO COMPARATOR

Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks.

Drug: Placebo

Interventions

EXPD-101/FXS7553 Dose 1 DRUG

Oral tablet

EXPD-101/FXS7553 Dose 1

EXPD-101/FXS7553 Dose 2 DRUG

Oral tablet

EXPD-101/FXS7553 Dose 2

Placebo DRUG

EXPD-101/FXS7553 - matching oral tablet.

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent for the study
• Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females)
• Diagnosis of COPD for at least 1 year
• COPD with physician-confirmed diagnosis of chronic bronchitis (persistent, productive cough and sputum for at least 3 months in the past year)
• At least 2 moderate or \> 1 severe exacerbation within 12 months prior to screening
• Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year);
• Stable maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per below:
• Dual therapy: long-acting beta-2 agonist/muscarinic antagonist (LABA/LAMA) or inhaled corticosteroids (ICS)/LAMA, or ICS/LABA OR
• Triple therapy: ICS/LAMA/LABA
• Post-BD FEV1/FVC \< 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening
• COPD Assessment Test (CAT) score ≥ 10 at Screening
• 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.
• Male participants commit to the following during the study and for at least 14 days after the last dose:
• Practice true sexual abstinence (refrain from heterosexual intercourse)
• 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).

You may not qualify if:

• COPD exacerbation within the 4 weeks prior to randomization.
• 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).
• Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection.
• Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1.
• 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.
• Evidence of active liver disease (with or without ongoing treatment)
• 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).
• Current or history, within the past year of Visit 1, of substance and/or alcohol abuse.
• History of cancer except:
• 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
• Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1
• 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.
• Known history of allergy or reaction to any component of the investigational product formulation
• 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
• Current long-term treatment with oxygen therapy \> 12 hours per day

Sponsors & Collaborators

• Expedition Therapeutics, Inc: lead

Study Sites (12)

DM Clinical Research - Phoenix

Phoenix, Arizona, 85012, United States

RECRUITING

California Medical Research Associates Inc.

Northridge, California, 91324, United States

RECRUITING

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

RECRUITING

Clinical Site Partners, LLC Leesburg dba Flourish Research

Leesburg, Florida, 34748, United States

RECRUITING

Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research

Miami, Florida, 33135, United States

RECRUITING

Optimal Research Sites

Orange, Florida, 32763, United States

RECRUITING

Centricity Research Columbus

Rincon, Georgia, 31326, United States

NOT YET RECRUITING

DM Clinical Research-Indianapolis

Indianapolis, Indiana, 46254, United States

RECRUITING

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

RECRUITING

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

DM Clinical Research- Tomball

Tomball, Texas, 77375, United States

RECRUITING

Burke Internal Medicine, Inc.

Burke, Virginia, 22015, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• James Duncan Chalmers, MBChB, PhD

  Radcliffe Department of Medicine, University of Oxford

  STUDY CHAIR

Central Study Contacts

Geoffrey Gilmartin, MD

CONTACT

617-775-9882; geoff.gilmartin@expeditiontx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: July 6, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 11, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)