RecruitingPHASE3INTERVENTIONAL

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

This study is for people in the UK who have pulmonary fibrosis (either idiopathic or progressive) and have already taken part in a previous study using a drug called nerandomilast (also known as BI 1015550). The main goal is to understand how well people can tolerate this treatment over a longer period. Researchers also want to find out if nerandomilast can improve how well your lungs work and if it can slow down how quickly your symptoms worsen, or delay the need for hospital stays. Participants will take nerandomilast tablets daily for up to nearly two years, while continuing their usual pulmonary fibrosis treatments. Regular doctor visits will track health and lung function.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Boehringer Ingelheim

Enrolment target

1,700

Start

06 May 2024

Estimated completion

05 May 2027

Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis

What is this study about?

This study is looking into a medication called nerandomilast for people who have a lung condition called pulmonary fibrosis. This condition causes scarring in the lungs, making it harder to breathe. There are different types, including Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), and this study includes people with either type.

The main aim of this study is to understand more about how nerandomilast works and if it's safe for people to take over a longer period. Researchers specifically want to see if it can help improve how well your lungs work. They also want to find out if it can slow down the speed at which your symptoms get worse, reduce the chances of needing to go to the hospital because of your lung condition, or help you live longer.

Only people who have already taken part in an earlier study with nerandomilast (also known as BI 1015550) can join this new study. Your doctors will keep a close eye on your health. This type of study, called a Phase 3 trial, often involves more people and aims to confirm the drug's benefits and safety before it can be widely used.

Key takeaways

This study is for long-term use of nerandomilast in people with pulmonary fibrosis.
Only participants from a previous nerandomilast study can join.
The study aims to check long-term safety and whether it helps lung function and slows disease progression.
You'll take daily tablets for almost two years and have regular check-ups.
You can continue your current pulmonary fibrosis medicines.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you must have already successfully completed treatment in one of the previous studies involving nerandomilast. This means you finished the treatment as planned, even if you had a short break from it.

Before taking part, you’ll need to officially agree to be in the study by signing a consent form. If you are a woman who could become pregnant, you'll need to use very effective birth control methods during the study. Similarly, men may also need to use birth control in some countries.

You cannot join the study if your doctor thinks you have another serious illness that would make it unsafe for you to participate. You also can't join if you have experienced certain thoughts or behaviours related to self-harm, or if you have severe depression or certain types of cancer, or if you are scheduled for a lung transplant.

Quick self-check

Have I previously completed a study involving nerandomilast?
Am I comfortable with regular doctor visits and lung function tests?
If I am a woman, am I able and willing to use highly effective birth control?
Do I have any other serious health conditions that my doctor thinks might make this study unsafe for me?
Am I not scheduled for a lung transplant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take nerandomilast as tablets every day for up to about one year and ten months. You can also continue taking any other regular medicines your doctor has prescribed for your pulmonary fibrosis during this time. You will need to visit your doctors regularly throughout the study.

During these visits, the doctors will check your general health and ask about any new symptoms or problems you might be having. You will also have regular tests to see how well your lungs are working. The total study duration, including all visits and follow-up, will involve taking the medication for a significant period.

Potential risks and benefits

Participating in this study might offer a chance to continue receiving a treatment that could potentially help manage your pulmonary fibrosis and improve your lung function. However, like all medications, nerandomilast could have side effects, and your doctors will closely monitor you for any health problems. There's also no guarantee that the treatment will be beneficial for you. You are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (373)

University of Alabama at Birmingham
Birmingham, United States· Recruiting
University of Arizona
Tucson, United States· Recruiting
University of Southern California
Los Angeles, United States· Recruiting
Cedars-Sinai Medical Center
Los Angeles, United States· Recruiting
University of California Los Angeles
Los Angeles, United States· Recruiting
University of California Davis
Sacramento, United States· Recruiting
National Jewish Health
Denver, United States· Recruiting
Yale University School of Medicine
New Haven, United States· Recruiting
Christiana Hospital
Newark, United States· Completed
Georgetown University
Washington D.C., United States· Recruiting
St. Francis Medical Institute
Clearwater, United States· Completed
University of Florida
Gainesville, United States· Recruiting

+361 more sites — see the official record for the full list.

Common questions

What is pulmonary fibrosis?

It's a lung condition where scar tissue builds up in your lungs, making them stiff and difficult to get enough oxygen.

Can I join if I've never taken nerandomilast before?

No, this study is only for people who have already completed a previous study where they received nerandomilast.

How long will I take the study drug?

You will take nerandomilast tablets for up to about one year and ten months.

Will I still take my regular lung medicine?

Yes, you can continue taking your usual pulmonary fibrosis treatments while in this study.

What kind of checks will I have?

You'll have regular doctor appointments to check your health and do tests to see how well your lungs are working.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.