EXPD-101 vs Placebo for Chronic Obstructive Pulmonary Disease

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

Recruiting Phase 2 Interventional Study
Chronic Obstructive Pulmonary Disease (COPD)
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Expedition Therapeutics, Inc · Industry
Who this trial is looking for

This trial is looking for people with chronic obstructive pulmonary disease (COPD) who have had recent flare-ups of their condition. Participants will take either the study drug or a placebo every day for a year.

Are You a Good Fit for This Trial?
Must be taking Dual or triple inhaled therapy for COPD
Rules you out AsthmaLung cancerActive liver disease

You may be able to join if

  • I have been diagnosed with COPD for at least 1 year.
  • I have a body mass index (BMI) of 18.5 to 35.
  • I have had at least 2 moderate or more than 1 severe flare-up in the past year.
  • I am a current or ex-smoker with a history of smoking of 10 pack-years or more.
  • I am stable on my COPD treatments for at least 3 months.
  • I have a COPD Assessment Test (CAT) score of 10 or higher.
  • If I am female and can get pregnant, I will practice effective birth control.
  • If I am male, I will take steps to prevent pregnancy in my partner.

You may not be able to join if

  • I have had a flare-up of my COPD within the last 4 weeks.
  • I have another serious lung disease, such as asthma or lung cancer.
  • I have a significant immune system problem or have tested positive for HIV.
  • I have had pneumonia that required treatment within the last month.
  • I have been diagnosed with significant liver disease.
  • I am currently abusing drugs or alcohol.
  • I have active periodontal disease or a tooth issue that may cause pain.
  • I am participating in a pulmonary rehabilitation program that started recently.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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.

Trial Locations
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Eligibility Criteria
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 (per…
Contacts

Geoffrey Gilmartin, MD

617-775-9882

geoff.gilmartin@expeditiontx.com

CONTACT