Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
This study is testing a new drug called rademikibart for people experiencing sudden severe worsening of their COPD, known as an acute exacerbation or 'flare-up'. Doctors are particularly interested in patients whose flare-ups are linked to something called 'type 2 inflammation'. In this study, some people will receive rademikibart along with their usual treatment, while others will get a dummy medicine (placebo) plus their usual treatment. It's a Phase 2 study, which means researchers are checking if the new medicine is safe and if it shows promise in helping patients, comparing it to standard care. The goal is to find better ways to manage these challenging COPD flare-ups.
At a glance
What is this study about?
Imagine your lungs are like a tree, with branches getting smaller and smaller, carrying air. In COPD, these airways become narrowed and swollen, making it hard to breathe. Sometimes, the symptoms suddenly get much worse – this is called a COPD 'flare-up' or 'acute exacerbation'. These flare-ups often require urgent medical care and can be quite serious.
This study is looking into a new medication called rademikibart to see if it can help people who are having one of these severe COPD flare-ups. Specifically, it's for those whose flare-up is linked to a particular type of body response called 'type 2 inflammation'. This type of inflammation is already known to play a role in certain lung conditions. Researchers want to understand if adding rademikibart to the usual treatments during a flare-up can make a difference.
It's a 'Phase 2' study, which means it's an important step in testing a new medicine. At this stage, doctors are looking to see if the drug is safe, how well it works, and what the best dose might be. Half the people in the study will get the new medicine plus their normal treatment, and the other half will get a dummy medicine (placebo) plus their normal treatment. This helps researchers fairly compare the new drug's effects.
Key takeaways
- This study is for people having a severe COPD flare-up.
- It tests a new medicine called rademikibart for flare-ups linked to specific body inflammation.
- Some people will get the new medicine, others a dummy medicine, alongside usual care.
- The goal is to find out if rademikibart is safe and helps improve outcomes for COPD flare-ups.
- You would receive close medical monitoring throughout your participation.
Who may be eligible?
To join this study, you need to be an adult between 40 and 80 years old, diagnosed with COPD for at least a year. You should have experienced at least one COPD flare-up in the past that needed steroid treatment, and your COPD flare-ups must currently require urgent medical help and steroids. Doctors will also check a blood test for a specific type of white blood cell (eosinophils) or a breath test (FeNO) to see if you have the 'type 2 inflammation' they are looking for.
There are also reasons why you might not be able to join. For example, if you have a history of asthma or a condition called Asthma COPD Overlap Syndrome, or if you have other serious breathing problems. Certain heart conditions, recent strokes, or other serious health issues like conditions that suppress your immune system (unless it's just mild skin cancer that's been successfully treated) would also mean you can't take part. If you regularly take certain strong medications that affect your immune system, or need oxygen for more than 15 hours a day, or are on long-term macrolide antibiotics, you would also be excluded.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 40 and 80 years old?
- Do you have COPD and currently experiencing a severe flare-up requiring urgent medical help?
- Have you had at least one COPD flare-up in the past that required steroid treatment?
- Do you NOT have asthma or Asthma COPD Overlap Syndrome?
- Are you NOT currently taking strong medications that suppress your immune system?
- Do you NOT need oxygen treatment for more than 15 hours a day?
What does participation involve?
If you decide to join this study, you'll be randomly assigned to one of two groups: one receiving rademikibart along with your standard COPD treatment, and the other receiving a dummy medicine (placebo) plus your standard treatment. Neither you nor your study doctor will know which treatment you are getting. The study drug is given as an injection using a pre-filled syringe.
Taking part will involve several visits to the study clinic, particularly during your acute flare-up, and possibly follow-up appointments. During these visits, you'll have various tests, such as blood tests, breathing tests, and physical examinations, to check your health and how you are responding to the treatment. The research team will explain the exact schedule of visits and what each involves. You’ll be carefully monitored throughout the study period.
Potential risks and benefits
Locations (51)
- University of Alabama at Birmingham Lung Health CenterVerified postcodeBirmingham, United States· Recruiting
- Leland Stanford Junior University, Stanford HospitalVerified postcodePalo Alto, United States· Recruiting
- Amicis Research CenterVerified postcodeValencia, United States· Recruiting
- National Jewish HealthVerified postcodeDenver, United States· Recruiting
- Synergy HealthcareVerified postcodeBradenton, United States· Withdrawn
- Columbus Clinical Services, LLCVerified postcodeMiami, United States· Recruiting
- Pharmax Research of South Florida, Inc.Verified postcodeMiami, United States· Recruiting
- Health Synergy Clinical Research, LLCVerified postcodeWest Palm Beach, United States· Recruiting
- Primeway Clinical Research GroupVerified postcodeFayetteville, United States· Recruiting
- Pivotal Research SolutionsVerified postcodeStonecrest, United States· Recruiting
- University of IowaVerified postcodeIowa City, United States· Recruiting
- University of Kansas Medical CenterVerified postcodeKansas City, United States· Recruiting
Common questions
What is type 2 inflammation?
Type 2 inflammation is a specific way your body's immune system reacts, often linked to conditions like allergies and asthma. Doctors in this study believe it might also be important in some COPD flare-ups.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the effects of the new medicine.
Will I know if I'm getting the new medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving rademikibart or the placebo. This is to ensure the study results are as fair as possible.
How is the study medicine given?
The study medicine is given as an injection using a pre-filled syringe.
What does 'Phase 2' mean for a clinical trial?
Phase 2 means the drug is being tested in a small group of people to see if it's safe, what dose works best, and if it shows promising signs of being effective for the condition.
How to find out more
Radha Adivikolanu
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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