A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
This research study is looking at a new medicine called CHF10067, also known as Zampilimab, for a lung condition called Idiopathic Pulmonary Fibrosis (IPF). IPF causes scarring in the lungs, making it harder to breathe. The main goal of this study is to see if two different doses of this new medicine are safe and if they help people with IPF over 24 weeks (about 6 months). Some participants will receive the new medicine, and others will receive a 'dummy' medicine (placebo) to compare the effects. This is a crucial step in finding potential new treatments for IPF, aiming to improve health and quality of life for those affected.
At a glance
What is this study about?
This study is about a lung condition called Idiopathic Pulmonary Fibrosis, or IPF. IPF is a serious illness where scar tissue builds up in your lungs, making them stiff and harder to work properly. This can lead to symptoms like breathlessness and a cough. Currently, there are treatments to help slow down IPF, but researchers are always looking for new and better ways to manage the condition.
That's where this study comes in. We are testing a new medicine called CHF10067, which also has the name Zampilimab. The main aim is to see if this new medicine is safe for people with IPF and if it can help improve their condition or slow down its progression. We'll be looking at two different amounts (doses) of the medicine over 24 weeks to understand how well it works and if there are any side effects.
This is a 'Phase 2' study, which means the medicine has already passed some initial safety checks, and now we're looking more closely at how effective it is and what dose might be best. It's a large study involving 240 people with IPF from many different countries, including the UK. Participants will be randomly given either one of the two doses of the new medicine or a 'placebo' – which looks like the real medicine but contains no active drug. This helps us fairly compare the effects and truly understand if CHF10067 is making a difference.
Key takeaways
- This study is testing a new medicine (CHF10067/Zampilimab) for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to find safe and effective doses of the medicine over 24 weeks.
- Participation involves regular hospital visits, tests, and taking either the new medicine or a placebo.
- You must be at least 40 years old and have a confirmed IPF diagnosis to be eligible.
- It's a 'Phase 2' study, focusing on the medicine's effectiveness and best dose.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To join this study, you would need to meet certain requirements. You must be at least 40 years old. You also need to have been officially diagnosed with Idiopathic Pulmonary Fibrosis (IPF) by a doctor in the last eight years, and this diagnosis would be confirmed by recent lung scans. Your lung function tests, which measure how well your lungs are working, also need to be within a certain range.
There are also some reasons why you might not be able to join. For example, if you have certain other serious health conditions, or if you've recently had a bad chest infection. The study also cannot include you if you've had lung cancer, or if your lung scans show a lot of another lung condition called emphysema. If your doctor thinks you might need a lung transplant in the next six months, you also wouldn't be able to take part.
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 40 years old?
- Do you have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
- Have your recent lung function tests shown specific results?
- Do you weigh at least 45 kg (about 7 stone 1 pound)?
- Have you *not* had certain serious chest infections recently?
- Are you *not* planning to have a lung transplant within the next 6 months?
What does participation involve?
If you decide to join this study, you would be randomly assigned to one of three groups: one group will receive one dose of the new medicine, another group will receive a different dose, and the third group will receive a placebo (a dummy medicine with no active drug). You, and your study doctor, won't know which group you're in – this is called 'double-blind' and helps ensure the study results are fair.
Throughout the study, you would attend regular appointments at the study site. These visits would involve various checks, such as physical exams, blood tests, lung function tests, and possibly more scans to see how your lungs are doing. You would take the study medicine as instructed by the research team. The main treatment part of the study lasts for 24 weeks (about 6 months), and there might be follow-up checks afterwards. You would have a dedicated study team supporting you throughout your participation.
Potential risks and benefits
Locations (19)
- SEC Clinical Research LLCVerified postcodeDothan, United States· Recruiting
- Pasadena Center for Medical Research, IncVerified postcodeSt. Petersburg, United States· Recruiting
- Hannibal Regional Healthcare System, Inc.Verified postcodeHannibal, United States· Recruiting
- Clinical Research of Rock HillVerified postcodeRock Hill, United States· Recruiting
- Tennessee Comprehensive Lung and Sleep CenterVerified postcodeHendersonville, United States· Recruiting
- Premier Pulmonary Critical Care and Sleep Medicine, PAVerified postcodeDenison, United States· Recruiting
- PHI University Clinic of Pulmonology and AllergologyVerified postcodeSkopje, North Macedonia· Recruiting
- Soon Chun Hyang University Bucheon HospitalVerified postcodeBucheon-si, South Korea· Recruiting
- Inje University Busan Paik HospitalVerified postcodeBusan, South Korea· Recruiting
- Inje University Haeundae Paik HospitalVerified postcodeBusan, South Korea· Recruiting
- Chonnam National University HospitalVerified postcodeGwangju, South Korea· Recruiting
- Kyung Hee University HospitalVerified postcodeSeoul, South Korea· Recruiting
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease where scar tissue builds up in your lungs, making them stiff and gradually harder to breathe. 'Idiopathic' means we don't know exactly why it starts.
What is CHF10067 (Zampilimab)?
It's the name of the new medicine being tested in this study. Researchers are hoping it could help people with IPF.
What does 'randomised, double-blind, placebo-controlled' mean?
It means you're put into a group by chance (randomised), neither you nor your doctor will know if you're getting the active medicine or a dummy one (double-blind), and some people get a dummy medicine (placebo) to compare effects fairly.
How long does the study last?
The main treatment period for participants is 24 weeks, which is about six months. There might be follow-up appointments after that.
Will I get paid for taking part?
The study information doesn't specify payment, but study teams often cover travel costs for appointments. This is a good question to ask the study staff.
How to find out more
Chiesi Clinical Trial Info
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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