Purpose of this Study
If you join this study, you will first go through a screening period to make sure you qualify. If you qualify, you will be placed into one of two groups by chance, like drawing names from a hat. Group 1 will get one dose of a medicine called rademikibart. Group 2 will get one dose of a placebo, which looks like the medicine but does not have any active drug. The study will include about nine visits over a period of eight to thirty‑four weeks.
Who Can Participate?
Eligibility
People can join this study if they are between 40 and 80 years old and have had COPD for at least one year. They must have had at least one COPD flare-up in the past year. They must be current or former smokers. They also cannot have asthma right now.
Age Range
40-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to learn if people who have COPD and Type 2 inflammation get better after a COPD flare‑up when they take a new medicine called rademikibart along with the regular COPD treatments their doctor already gives them.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
Principal Investigator
Matthew
McCravy
Protocol Number
PRO00119174
NCT ID
NCT06940154
Phase
II
Enrollment Status
Pending Open to Enrollment