OBERON (Chronic Obstructive Pulmonary Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called tozorakimab (the study drug) will work and be safe for treating COPD patients who have a history of COPD exacerbations (also called flare-ups, which is when your COPD gets worse).

What is the Condition Being Studied?

Chronic Obstructive Pulmonary Disorder (COPD)

Who Can Participate in the Study?

Adults ages 40+ who:

- Are diagnosed with COPD for at least one year

- Currently use inhaler medications for COPD management (Inhaled Corticosteroid/LAMA/LABA triple therapy)

- Are current or former smokers

- Do not have a current diagnosis of asthma

For more information about this study, please contact the study coordinator at jessica.shier@duke.edu or (919) 684-9139.

Age Group
Adults

What is Involved?

If you choose to join this study, you will go through a screening process that lasts at least 2 weeks and up to 12 weeks, which will include breathing tests, ECG, CT scan, and blood draws.

If you are eligible to participate, you will:

- Get a random assignment (like drawing numbers from a hat) to 1 of 3 groups

-- Group 1 will get a dose of the study drug every 4 weeks

-- Group 2 will get a dose of the study drug every 8 weeks alternating with a placebo (i.e., Week 0 = study drug, Week 4 = placebo, Week 8 = study drug, and so on)

-- Group 3 will get placebo every 4 weeks

A placebo is an inactive substance that has no medicinal properties. You will receive the study drug or placebo as an injection every 4 weeks for a year (13 doses altogether).

Study Details

Full Title
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (OBERON)
Principal Investigator
Pulmonologist
Protocol Number
IRB: PRO00110508
NCT: NCT05166889
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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