A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults with Idiopathic Pulmonary Fibrosis (SURPASS-IPF)
Idiopathic pulmonary fibrosis (IPF) is a condition that causes progressive scarring in the lungs, making it harder to breathe deeply. This Phase 3 clinical trial compares an experimental medicine called LYT-100 (deupirfenidone) directly with pirfenidone, a standard drug already used to treat IPF. Researchers want to find out whether LYT-100 is safe and if it can slow down the loss of lung function as well as, or better than, pirfenidone. The main test used is forced vital capacity (FVC), which measures the maximum amount of air you can breathe out in one breath. The study lasts for 52 weeks (one year). Adults aged 18 and over who have been diagnosed with IPF may be able to take part. Half of the participants will receive the new medicine, while the other half will receive standard pirfenidone.
At a glance
What is this study about?
Idiopathic pulmonary fibrosis, or IPF, is a serious long-term lung condition. Over time, the tissue inside the lungs becomes thick, stiff, and scarred. This makes it difficult for the lungs to take in oxygen and expand fully, leading to breathlessness and a persistent dry cough. While current treatments can help slow the scarring, they do not cure IPF, and some people struggle with unpleasant side effects.
This trial is testing a new tablet called LYT-100 (deupirfenidone). LYT-100 is a modified version of pirfenidone, an established medicine for IPF. Scientists modified the medicine with the goal of helping it stay in the body longer and potentially causing fewer side effects, such as stomach upset or nausea, while still protecting lung health.
Because this is a Phase 3 trial, it is one of the final stages of testing before a new medicine can be approved for general use. The study directly compares LYT-100 to pirfenidone over 52 weeks to see how both drugs affect lung capacity and overall health. Finding treatments that are easier to tolerate and just as effective could make a major difference to the daily lives of people living with IPF.
Key takeaways
- Phase 3 trial comparing a new medicine (LYT-100) to an approved medicine (pirfenidone) for IPF.
- Aims to check if LYT-100 protects lung function over 52 weeks.
- Every participant receives an active treatment; there is no dummy pill (placebo).
- Open to adults aged 18 and over with an IPF diagnosis.
- Taking part involves daily tablets and regular hospital visits for breathing and blood tests.
Who may be eligible?
This study is designed for adults aged 18 and older who have a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF). Both men and women can join.
To take part, your lungs must still have enough working capacity to safely participate in the trial tests, and you must be willing to attend regular hospital appointments over a 52-week period.
You might not be able to take part if you have other severe lung disorders, serious heart or liver problems, or if you are taking certain other medications that could clash with the trial drugs. The trial team will carry out detailed health checks to make sure joining is safe 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.
- I am aged 18 or older.
- I have been diagnosed with idiopathic pulmonary fibrosis (IPF).
- I am able to attend regular hospital appointments over a 12-month period.
- I am willing to take daily study tablets as directed.
- I can perform basic breathing tests to measure my lung capacity.
What does participation involve?
If you decide to take part, your participation will last for about 52 weeks (one full year). You will be randomly placed into one of two groups: one group takes LYT-100 and the other takes pirfenidone. Neither you nor your doctor will know which pill you are taking, which ensures the results are completely unbiased.
You will take your assigned study capsules by mouth each day. During the year, you will visit the hospital clinic regularly for routine check-ups. At these visits, staff will monitor your health, take blood tests, and perform simple breathing tests (called spirometry) to measure how much air your lungs can hold. You will also be asked about any side effects or changes in how you feel.
Potential risks and benefits
Locations (12)
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedPortugal
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedRomania
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
What is idiopathic pulmonary fibrosis (IPF)?
IPF is a condition where lung tissue becomes scarred and stiff over time, making it harder to breathe normally.
What is LYT-100?
LYT-100 is a modified version of an existing IPF drug called pirfenidone, designed to work well while hopefully being easier on the stomach.
Will I receive a dummy pill (placebo)?
No. This is a 'head-to-head' study, meaning everyone receives active medicine: either the new drug (LYT-100) or the standard drug (pirfenidone).
What is Forced Vital Capacity (FVC)?
FVC is a simple breathing test that measures the total volume of air you can forcefully blow out after taking a deep breath.
Can I leave the study early if I want to?
Yes. You are free to stop taking part at any point, and your standard medical treatment will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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