Search > Chronic Obstructive Pulmonary Disease
600 Participants NeededMy employer runs this trial

EXPD-101 for COPD

(Navigator Trial)

Recruiting at 19 trial locations
GG
Overseen ByGeoffrey Gilmartin, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Expedition Therapeutics, Inc
Must be taking: Dual or triple inhaled therapy
Must not be taking: Biologics for COPD
Disqualifiers: Asthma, Lung cancer, HIV, others
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

JD

James Duncan Chalmers, MBChB, PhD

Principal Investigator

Radcliffe Department of Medicine, University of Oxford

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with COPD (chronic obstructive pulmonary disease), including those with chronic bronchitis. Participants should be able to take daily medication and meet other health requirements set by the study team.

Inclusion Criteria

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)
Post-BD FEV1/FVC < 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening
See 8 more

Exclusion Criteria

I have not had pneumonia needing antibiotics or antivirals in the past 28 days.
I have had a COPD flare-up in the last 4 weeks.
I do not have a weakened immune system or hepatitis B, hepatitis C, or HIV.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EXPD-101 or placebo once daily for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing two different doses of a new drug, EXPD-101/FXS7553, compared to a placebo. Participants are randomly assigned to one of these groups and will take their assigned treatment once daily for 52 weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: EXPD-101/FXS7553 Dose 2Experimental Treatment1 Intervention
Group II: EXPD-101/FXS7553 Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Expedition Therapeutics, Inc

Lead Sponsor

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.