Active not recruitingPHASE2INTERVENTIONAL

A Study of Mosliciguat in PH-ILD

This study is testing a new inhaled medicine called mosliciguat for people who have pulmonary hypertension (high blood pressure in the lungs) linked to interstitial lung disease (lung scarring), often called PH-ILD. Doctors want to see if this medicine is safe and effective in treating this condition. Participants will be randomly put into one of two groups: one receiving the new medicine through an inhaler, and the other receiving a placebo (a dummy medicine with no active ingredients). This helps researchers understand if any changes are truly due to the new medicine. The study has two parts: an initial 24-week period where participants receive either the active medicine or placebo, followed by an optional extension where all participants will receive the active medicine.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Pulmovant, Inc.

Enrolment target

135

Start

29 Oct 2024

Estimated completion

01 Jan 2028

Pulmonary Hypertension Interstitial Lung Disease Lung Diseases Vascular Diseases Cardiovascular Diseases Fibrosis

What is this study about?

This study is designed to learn more about a new medicine called mosliciguat. This medicine is given through an inhaler, similar to how some asthma medicines are used. The study focuses on people who have a condition called PH-ILD. This means they have high blood pressure in the arteries of their lungs (pulmonary hypertension) which is caused by scarring in their lungs (interstitial lung disease).

The main goal of this study is to see if mosliciguat is safe to use for people with PH-ILD and if it can help improve their symptoms or condition. Finding new treatments for PH-ILD is important because it's a serious condition that can make breathing difficult and affect daily life.

By taking part, you would be helping doctors and researchers understand more about PH-ILD and potentially find a new way to treat it. The information gathered from this study could benefit many people in the future who are living with this condition.

Key takeaways

This study investigates a new inhaled medicine (mosliciguat) for PH-ILD.
It aims to check the safety and effectiveness of the medicine.
Participants will be randomly assigned to receive either mosliciguat or a placebo for 24 weeks.
There's an option to continue with mosliciguat in an extension period.
Your participation could help advance future treatments for PH-ILD.

Who may be eligible?

To join this study, you would need to be aged between 18 and 85 years old. You must have a confirmed diagnosis of interstitial lung disease (ILD), which is a type of lung scarring, and also have high blood pressure in your lungs (pulmonary hypertension). Doctors will confirm these conditions with special tests like a CT scan of your lungs and a heart catheterisation procedure.

Some specific types of lung scarring are included, such as Idiopathic Interstitial Pneumonia, chronic hypersensitivity pneumonitis, or ILD linked to connective tissue disease, but your breathing capacity needs to be above a certain level. You also need to be able to walk at least 100 meters (about the length of a football pitch) in a 6-minute test.

There are also reasons why you might not be able to join. For example, if you have other specific types of pulmonary hypertension that are not related to your lung scarring, or if your lung condition has worsened significantly recently. You also can't be taking a very high amount of oxygen (more than 10 litres per minute) or have had a bad reaction to similar medicines before.

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 between 18 and 85 years old?
Do you have confirmed lung scarring (ILD) and high blood pressure in your lungs (PH)?
Can you walk at least 100 metres in 6 minutes?
Have you *not* had your lung condition get much worse recently needing hospitalisation?
Are you *not* using more than 10 litres of oxygen per minute at rest?
Are you *not* on certain other types of pulmonary hypertension medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to sign a consent form, which explains everything in detail. The study is divided into two main parts. For the first 24 weeks, you would be randomly assigned to receive either the study medicine (mosliciguat) through an inhaler or a placebo (a dummy inhaler with no active medicine).

During this initial 24-week period, you would have regular visits to the study clinic for check-ups, tests, and to receive your study medicine. These visits would involve things like physical exams, blood tests, breathing tests, and possibly scans or heart checks to see how you are responding. After these 24 weeks, if you choose to continue and meet certain conditions, you would enter an extension period. In this second period, everyone receives the active study medicine.

The exact number and type of visits, tests, and amount of medicine will be fully explained by the study team. You would use the inhaler as directed, and the total length of your involvement could be more than 24 weeks if you join the extension period.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new medicine helps your condition, but there's no guarantee. You might also gain a better understanding of your health through regular check-ups. However, there are also potential risks, as with any medicine. Mosliciguat could have side effects, which would be explained in full detail by the study team. Some of the tests might also have minor discomforts or risks. You will be closely monitored for any problems. It is very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (85)

Clinical Research Site
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Phoenix, United States
Clinical Research Site
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Los Angeles, United States
Clinical Research Site
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Sacramento, United States
Clinical Research Site
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Santa Barbara, United States
Clinical Research Site
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Torrance, United States
Clinical Research Site
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Washington D.C., United States
Clinical Research Site
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Celebration, United States
Clinical Research Site
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Chicago, United States
Clinical Research Site
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Iowa City, United States
Clinical Research Site
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Kansas City, United States
Clinical Research Site
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Louisville, United States
Clinical Research Site
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Boston, United States

Common questions

What is PH-ILD?

PH-ILD stands for pulmonary hypertension associated with interstitial lung disease. It means you have high blood pressure in your lungs caused by scarring in your lung tissue.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers see if the real medicine is having an effect.

Will I know if I'm getting the real medicine or the placebo?

No, during the first 24 weeks, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is called 'double-blind' and ensures fair testing.

How is the medicine given?

The study medicine, mosliciguat, is given using a dry powder inhaler, similar to some asthma medicines.

How long will I be in the study?

The first part of the study lasts 24 weeks. If you choose to, and are eligible, you might continue into an extension period, making your total time in the study longer.