What is EXPD-101 studying for COPD?

EXPD-101 is being studied to understand its effects on treating Chronic Obstructive Pulmonary Disease (COPD). Researchers aim to evaluate the drug's safety, how well it works to reduce COPD flare-ups, and how it is processed by the body during one year of treatment.

Who may be eligible for this COPD clinical trial?

Adults aged 40 to 85 with a COPD diagnosis for at least one year may be eligible. Participants should have a history of smoking, confirmed chronic bronchitis, and recent COPD exacerbations. Please review eligibility criteria for more details.

Is there any cost to participate in this COPD clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 40Years - 85Years

All Genders

ID07684820

Phase 2 Evaluation of Two EXPD-101 Doses Versus Placebo in Adults with COPD Over One Year

Led by Expedition Therapeutics, Inc · Updated on 2026-08-07

600

Participants Needed

Research Sites

1 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, safety, tolerability, and how the body processes two different doses of the drug EXPD-101 in adults with Chronic Obstructive Pulmonary Disease COPD. This phase 2 study compares these two doses against a placebo to better understand treatment options for COPD over a year. Participants will be randomly assigned to one of three groups one receiving EXPD-101FXS7553 Dose 1, another receiving Dose 2, or a third receiving a placebo. Each participant will take their assigned oral tablet once daily for 52 weeks. The study will closely monitor these treatments throughout this year-long period. During the study, participants will undergo regular evaluations including physical exams, vital sign checks, electrocardiograms ECGs, and laboratory tests. Researchers will measure the number of moderate and severe COPD flare-ups, changes in lung function, quality of life, and any side effects or abnormalities. Blood samples will be collected at multiple time points to study the drugs presence and metabolism. The total participation time is approximately one year, with continuous safety and health monitoring throughout.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Provided written informed consent for the study
Body mass index (BMI) between 18.5 and less than 35 kg/m2 at screening (weight at least 50 kg for males and 45 kg for females)
Diagnosis of COPD for at least 1 year
Physician-confirmed chronic bronchitis with persistent cough and sputum for at least 3 months in the past year
At least 2 moderate or more than 1 severe COPD exacerbation within 12 months prior to screening
Current or former smokers with a history of at least 10 pack-years
Stable maintenance therapy with dual or triple inhaled therapy for at least 3 months prior to enrollment
Post-bronchodilator FEV1/FVC ratio less than 0.7 and FEV1 predicted at least 40% at screening
COPD Assessment Test (CAT) score of 10 or higher at screening
If of childbearing potential, commitment to effective birth control and not donating eggs during the study and for at least 14 days after last dose
Male participants must commit to sexual abstinence or use of condoms with partners of childbearing potential, be vasectomized at least 3 months before screening, and refrain from donating sperm during and for 14 days after the study

You will not qualify if you...

COPD exacerbation within 4 weeks prior to randomization
Significant lung diseases other than COPD, such as asthma, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, lung cancer, alpha-1 antitrypsin deficiency, or tuberculosis
Significant immunodeficiency or positive tests for hepatitis B, hepatitis C, or HIV infection
Pneumonia requiring antibiotics or antiviral treatment within 28 days before first visit
Clinically significant infection requiring antibiotics or antivirals within 14 days before first visit
Active liver disease
QT interval corrected with Fridericia's formula greater than 450 msec (or 480 msec with bundle branch block) on screening ECG
Substance or alcohol abuse within the past year
History of cancer except certain skin or cervical cancers treated at least 12 months ago or other cancers treated at least 5 years ago
Clinically significant abnormalities in exams or labs at screening that may risk participation or affect study results
Allergy or reaction to any study drug component
Current treatment with COPD biologic drugs or recent use within 5 half-lives or 4 months
Long-term oxygen therapy more than 12 hours per day
Use of immunoglobulin or blood products within 30 days before screening
Recent live attenuated vaccine within 30 days before screening
Participation in acute phase of pulmonary rehabilitation started less than 4 weeks before screening
History or active conditions causing non-hereditary palmoplantar keratosis
Untreated teeth that may cause pain or infection
Active periodontal disease currently treated or expected to require treatment during study
Scheduled tooth extraction during study period

Research Team

Geoffrey Gilmartin, MD

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Phase 2 Evaluation of Two EXPD-101 Doses Versus Placebo in Adults with COPD Over One Year

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria