A Phase IIb, multicentre, randomised, doubleblind, placebocontrolled, three-arm parallel-group study to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab), with an optional 24-week doubleblind, placebocontrolled extension phase in participants with idiopathic pulmonary fibrosis
This research study is looking into a new treatment called zampilimab for a lung condition called idiopathic pulmonary fibrosis (IPF). IPF causes scarring in the lungs, making it harder to breathe. The study wants to find out if zampilimab is safe and effective in slowing down this scarring. Participants will receive either one of two doses of zampilimab or a placebo (a dummy medicine) through a drip. The main part of the study lasts 24 weeks, during which doctors will check how you are doing. There's also a chance to continue for another 24 weeks if you wish. This is a "Phase II" study, meaning it's an early step in testing new medicines.
At a glance
What is this study about?
Idiopathic pulmonary fibrosis (IPF) is a serious lung disease where the lungs become scarred and stiff over time, making it difficult to breathe. Doctors don't fully understand why it happens, which is why it's called 'idiopathic' (meaning 'of unknown cause'). While there are some treatments available, researchers are always looking for new and better ways to help people living with IPF.
This study is testing a new medicine called zampilimab. Zampilimab is an investigational drug, meaning it's still being studied and is not yet approved for general use. The main goal of this particular study is to see if zampilimab is safe for people with IPF and if it can help improve their lung condition or slow down its progression. The researchers are comparing two different doses of zampilimab against a placebo (a treatment that looks like the real medicine but doesn't contain any active drug) to understand its potential effects.
By taking part, you would be helping doctors learn more about IPF and potentially discover new ways to treat it in the future. The information gathered from this study will help decide if zampilimab should be studied further in larger groups of people.
Key takeaways
- This study is testing a new medicine called zampilimab for IPF.
- It aims to check the safety and effectiveness of two different doses.
- Some participants will receive a placebo (dummy treatment).
- The initial study period is 24 weeks, with an optional extension.
- Regular clinic visits, blood tests, and lung function tests are part of taking part.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study looks for people who have been diagnosed with idiopathic pulmonary fibrosis (IPF).
There might be other health conditions or medicines that would prevent you from taking part, as doctors need to make sure the study is as safe as possible for everyone involved. For example, if you have certain other serious health problems or are taking specific medications, this might mean you can't join.
It's important to discuss your full medical history with the study doctor and nurses, as they will check all the details to make sure this study is right for you.
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 at least 18 years old?
- Have you been diagnosed with idiopathic pulmonary fibrosis (IPF)?
- Are you able to attend regular clinic visits?
- Are you willing to receive treatment through a drip (IV infusion)?
What does participation involve?
If you decide to take part, you would be in the study for at least 24 weeks. The study involves receiving the treatment (either zampilimab or placebo) through an intravenous (IV) drip, which means it will go directly into your bloodstream. You'll have regular visits to the clinic, where the study team will carry out various assessments. These will happen at the start, and then at weeks 6, 12, 18, 24, and 30.
These assessments will include physical examinations, blood tests, and lung function tests to check how you are responding to the treatment and to monitor your health. After the initial 24 weeks, there's an option for you to continue in the study for another 24 weeks, still receiving either the study drug or placebo, so the total time could be up to 48 weeks.
Potential risks and benefits
Locations (10)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedBulgaria
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedPortugal
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
What is idiopathic pulmonary fibrosis (IPF)?
IPF is a serious lung disease where the lungs become scarred and stiff, making it hard to breathe. The cause isn't fully understood.
What is zampilimab?
Zampilimab is a new medicine being tested for IPF. It's not yet approved and is investigational.
What is a placebo?
A placebo is a dummy treatment that looks like the real medicine but has no active drug. It helps researchers compare the new medicine's effects.
How long does the study last?
The main part of the study is 24 weeks, but there's an option to continue for another 24 weeks, making it up to a total of 48 weeks.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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