RecruitingPhase IIIInterventional

A Phase III trial of inhaled mosliciguat in pulmonary hypertension associated with interstitial lung disease

Interstitial lung disease causes scarring and stiffening in the lungs. Over time, this damage can lead to high blood pressure in the lung arteries, making simple daily tasks and walking feel exhausting. This clinical trial is evaluating whether a new inhaled medicine, called mosliciguat, can help. The study involves adults aged 18 to 85 who have this combined lung and blood pressure condition. Participants will be randomly chosen to receive either mosliciguat or a dummy treatment (placebo) using an inhaler for 24 weeks. Researchers will measure how well the treatment works by seeing how far participants can walk in six minutes. Those who finish the initial 24-week period can join an extension phase where everyone receives mosliciguat. The goal is to discover whether this inhaled medicine is safe, well-tolerated, and effective at improving everyday physical stamina.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Pulmovant, Inc.

Enrolment target

376

Start

31 Aug 2026

Estimated completion

28 Jan 2029

Pulmonary hypertension associated with interstitial lung disease

What is this study about?

Interstitial lung disease (ILD) is a group of conditions that cause inflammation and permanent scarring in the lung tissue. This scarring makes the lungs stiff, which can make it hard to get enough oxygen into the bloodstream. In many patients, this damage also puts pressure on the blood vessels running through the lungs, causing a form of high blood pressure known as pulmonary hypertension. Together, this is called PH-ILD. Living with PH-ILD can cause severe breathlessness, tiredness, and limits on everyday activities.

Mosliciguat is an experimental medicine designed to be inhaled directly into the airways. Once inside the lungs, it aims to relax and widen the narrowed blood vessels. By opening these vessels, the drug may lower blood pressure in the lungs, take strain off the heart, and make it easier for people to breathe and stay active. This trial is comparing mosliciguat against a placebo (an identical-looking inhaler with no active medicine) to see if it truly helps people walk further.

Finding new ways to treat this condition is vital because current treatment options are very limited. If the study shows that mosliciguat is safe and helps people walk with greater ease, it could lead to an important new treatment that helps people with PH-ILD maintain their mobility and quality of life.

Key takeaways

Tests an inhaled medicine designed to lower blood pressure in the lungs for people with lung scarring.
Aimed at adults aged 18 to 85 who can walk at least 100 metres in six minutes.
Participants take either the real medicine or a dummy inhaler for the first 24 weeks.
Everyone who finishes the main study can choose to receive the active medicine in a follow-on study.
Joining is completely voluntary and you can stop taking part at any time.

Who may be eligible?

This study is open to adults aged 18 to 85 who have pulmonary hypertension linked to interstitial lung disease. Your lung scarring must be confirmed by a detailed chest scan, and your lung blood pressure must have been checked using a standard test called a right heart catheterisation. To take part, you must also be able to walk at least 100 metres during a six-minute walking test.

You cannot take part if your pulmonary hypertension is caused by other issues, such as left-sided heart disease or blood clots in the lungs. You will also not be eligible if you have had a sudden flare-up of your lung disease or a hospital stay within the past 4 weeks, or if you need more than 10 litres of oxygen per minute while resting.

Finally, people who have recently started a pulmonary rehabilitation exercise programme, those who had a bad reaction to similar medicines in the past, or those who have taken part in another clinical trial very recently will not be able to join.

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?
Have you been diagnosed with high blood pressure in the lungs caused by lung scarring (PH-ILD)?
Can you walk at least 100 metres in six minutes without stopping completely?
Has your lung condition been stable without hospital stays or treatment changes in the last month?
Do you use 10 litres per minute or less of resting oxygen?

Answer every question to see your result.

What does participation involve?

Taking part in the main study lasts for about 24 weeks (around six months). At the beginning, a computer will randomly assign you to breathe in either mosliciguat or a placebo dummy medicine. You have an equal chance of receiving either one, and neither you nor your doctor will know which one you are taking.

You will use an inhaler to take your medicine as instructed by the study team. You will need to attend regular clinic appointments so doctors can check your heart, lungs, and general wellbeing. During these visits, you will perform simple checks, including a six-minute walk test, blood pressure checks, and questionnaires about how your breathing affects your daily life. If you complete the full 24 weeks safely, you will have the choice to join an extension study where all participants receive the active mosliciguat medicine.

Potential risks and benefits

Because mosliciguat is still being tested, there is no guarantee that it will improve your health or breathing, and you might receive a dummy inhaler for the first six months. However, your involvement could help doctors discover better treatments for people with this condition in the future. Inhaling the medicine may cause unwanted side effects, such as a cough, dizziness, or changes in blood pressure. The study doctors will monitor your health very closely throughout the trial to keep you safe and manage any problems. Taking part is entirely your choice, and you can change your mind and leave the trial at any time without your regular NHS medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Brompton Hospital
Unverified
London, England

Common questions

What is a placebo?

A placebo is a dummy treatment designed to look and feel just like the real medicine, but it contains no active drug. It helps researchers prove whether any improvements are truly due to the new medicine.

Will I definitely receive the study medicine?

During the first 24 weeks, you have a 50% chance of receiving mosliciguat and a 50% chance of receiving the placebo. However, if you complete this first stage, you can choose to join an extension study where everyone receives mosliciguat.

How do I take the medicine?

The medicine is inhaled directly into your lungs through a handheld inhaler device. The clinical team will teach you how to use it properly.

What is the six-minute walk test?

It is a standard test where you walk at your own comfortable pace along a flat corridor for six minutes. The team records how far you manage to walk to see if the treatment improves your exercise tolerance.

Can I leave the study if I feel it is not right for me?

Yes, you are free to withdraw from the trial at any point, for any reason. Leaving the study will never affect the quality of your regular medical treatment.

How to find out more

Jennifer Cormier

clinicaltrials@pulmovant.com +1 (0)9194631310 Official trial record

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