To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorExpedition Therapeutics, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EXPD-101/FXS7553 Dose 1
- EXPD-101/FXS7553 Dose 2
- Placebo
Treatment groups
600 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov