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).
Who Can Participate?
Eligibility
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.
- 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.
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).
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)
MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (OBERON)
Principal Investigator
Loretta
Que
Protocol Number
PRO00110508
NCT ID
NCT05166889
Phase
III
Enrollment Status
OPEN TO ACCRUAL