A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis
This research is investigating new investigative treatments for adults living with Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and stiff, making it hard to breathe. In this study, we're testing a new medicine called ABBV-142. Some participants will receive this new medicine, while others will receive a 'placebo' – a dummy treatment that looks like the real medicine but contains no active drug. This helps us understand if the new medicine is genuinely effective. The main goal is to see how much lung function, specifically how much air you can breathe out forcefully (called 'forced vital capacity'), changes after 24 weeks. We'll also track changes over a longer period, up to 52 weeks, and look at other measures of lung health.
At a glance
What is this study about?
This research is a 'Phase 2a' study, which means it's an early-stage study to explore the effects of a new medicine. We're focusing on Idiopathic Pulmonary Fibrosis (IPF), a serious and progressive lung disease. In IPF, the tissues in your lungs become scarred and thickened, making it increasingly difficult to get enough oxygen. Currently, there are treatments available that can help slow down the progression of IPF, but more effective options are still needed.
This study aims to find out if a new medicine, code-named ABBV-142, can help people with IPF. To do this, we'll compare its effects against a 'placebo.' A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. By comparing the new medicine to a placebo, doctors can determine if any improvements or changes are truly due to the medicine itself and not just other factors or a 'placebo effect.'
The main thing we want to measure is how much your lung function changes. Specifically, we'll be looking at something called 'forced vital capacity' (FVC), which is the total amount of air you can forcefully exhale after taking a deep breath. We'll track these changes over 24 weeks, and then continue to monitor participants for up to 52 weeks to see the longer-term effects. We hope to find out if this new medicine can help preserve lung function in people with IPF.
Key takeaways
- This study evaluates a new treatment for Idiopathic Pulmonary Fibrosis (IPF).
- It compares a new medicine (ABBV-142) against a dummy treatment (placebo).
- The main goal is to see if lung function improves over 24 weeks.
- Participation involves regular clinic visits, tests, and taking the study medicine/placebo.
- The study includes adults aged 18 and over with a confirmed IPF diagnosis.
- You can stop participating at any time if you choose.
Who may be eligible?
This study is open to both men and women. To be considered, you must be at least 18 years old; there is no upper age limit for participation.
You would need to have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). The study team will review your medical history and conduct tests to make sure you meet all the specific criteria for getting into the study.
There will also be other requirements, such as certain health conditions you can't have, or medications you can't be taking, as these could affect your safety or the study results. The study doctor will explain all of these to you carefully.
- Are you at least 18 years old?
- Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF)?
- Are you able to attend regular clinic appointments for about a year?
- Are you comfortable potentially receiving a placebo instead of the active drug?
- Are you able to follow study instructions, including taking medication regularly?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would be assigned to either receive the new investigative medicine (ABBV-142) or a placebo (dummy treatment). You won't know which one you're receiving, and neither will the study team, to keep the results fair.
You would have several visits to the clinic over the course of the study. These visits will involve various assessments, such as lung function tests (like the forced vital capacity test), blood tests, and physical examinations to monitor your health and how you're responding to the treatment. You would likely take the study medicine or placebo regularly, as instructed by the study team.
The main part of the study where the key treatment effects are measured will last for 24 weeks. However, you would be followed up for a total of 52 weeks to see the longer-term effects and ensure your safety.
Potential risks and benefits
Locations (11)
- —Greece
- —Italy
- —Sweden
- —Germany
- —Portugal
- —Spain
- —France
- —Hungary
- —Poland
- —Bulgaria
- —Romania
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease where your lungs become scarred and stiff without a known reason, making it harder to breathe over time.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the study medicine but contains no active drug. It helps researchers see if the real medicine is truly effective.
How long will I be in the study?
The main treatment period is 24 weeks, but you'll be followed for a total of 52 weeks to monitor your health and the medicine's effects.
What is 'forced vital capacity' (FVC)?
FVC is a common lung test that measures how much air you can breathe out forcefully after taking the deepest breath possible.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, and your medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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