Study on the Effects of Mosliciguat for Patients with Pulmonary Hypertension Linked to Interstitial Lung Disease

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What is this study about?

This clinical trial is focused on studying Pulmonary Hypertension Associated with Interstitial Lung Disease. Pulmonary hypertension is a condition where there is high blood pressure in the blood vessels that supply the lungs, and interstitial lung disease refers to a group of disorders that cause scarring of lung tissue. The treatment being tested in this study is called Mosliciguat, which is administered as an inhalation powder using a device known as a dry powder inhaler. The purpose of the study is to assess the effectiveness and safety of Mosliciguat in reducing the resistance in the blood vessels of the lungs over a period of 16 weeks.

Participants in the study will be randomly assigned to receive either Mosliciguat or a placebo. The study will last for about a year, during which participants will use the inhaler daily. The main focus will be on measuring changes in the blood flow resistance in the lungs at the end of 16 weeks. Additionally, the study will look at changes in the distance participants can walk in six minutes and levels of a specific protein in the blood that can indicate heart stress.

This trial aims to provide valuable information on whether Mosliciguat can help improve the condition of patients with pulmonary hypertension associated with interstitial lung disease. The results could potentially lead to new treatment options for managing this challenging condition.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the details and potential risks of the trial.

2 initial assessments

You will undergo a series of initial assessments to confirm your eligibility. This includes a high-resolution computerized tomography (HR-CT) scan to confirm the diagnosis of interstitial lung disease and a right heart catheterization to confirm pulmonary hypertension.

You will also perform a 6-minute walk test to measure your ability to walk a certain distance in six minutes.

3 medication administration

You will be randomly assigned to receive either the study medication, mosliciguat, or a placebo. The medication is administered as an inhalation powder.

The dosage and frequency of administration will be explained to you by the study team. The treatment period lasts for 16 weeks.

4 ongoing assessments

Throughout the 16-week period, you will have regular assessments to monitor your health and the effects of the medication. This includes repeated right heart catheterizations to measure changes in pulmonary vascular resistance.

You will also have follow-up 6-minute walk tests and blood tests to measure NT-proBNP levels, which help assess heart function.

5 end of treatment evaluation

At the end of the 16-week treatment period, a final evaluation will be conducted. This includes a comprehensive assessment of your health and any changes in your condition.

The results will help determine the effectiveness and safety of the study medication.

Who Can Join the Study?

Participants must be willing and able to provide informed consent, which means they understand the study and agree to take part.
Participants must have a diagnosis of Interstitial Lung Disease (ILD). This diagnosis will be confirmed by a special type of scan called a high-resolution computerized tomography (HR-CT) scan, which shows lung disease. Eligible types of ILD include:
- Idiopathic interstitial pneumonia (IIP)
- Chronic hypersensitivity pneumonitis
- ILD associated with connective tissue disease (CTD) with a lung function test result called forced vital capacity (FVC) less than 70% of what is predicted for a healthy person.
Participants must have confirmed pulmonary hypertension (PH), which is high blood pressure in the lungs, diagnosed by a procedure called right heart catheterization (RHC).
Participants must be able to walk at least 100 meters in a test called the 6-minute walk distance (6MWD).
Participants can be of any gender.
Participants must be within the age range specified by the study.

Who Cannot Join the Study?

Patients with other serious heart or lung diseases that are not related to the study condition.
Patients who have had a heart attack or stroke in the last 6 months.
Patients who have uncontrolled high blood pressure.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse in the past year.
Patients who have a known allergy to the study medication.
Patients who have been diagnosed with cancer in the past 5 years, except for skin cancer that is not melanoma.
Patients who have severe liver or kidney disease.
Patients who have an infection that requires treatment with antibiotics.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Hospital Universitario 12 De Octubre	Madrid	Spain
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l.	Palermo	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fakultni Thomayerova nemocnice	Prague	Czechia
Hospital Costa del Sol	Marbella	Spain
Mwaozwsmhhqgcnqxxbhujqxpla Hexmefgayplukdor	Halle (Saale)	Germany
Hrzrvgzo Ufykpepulpzei Mpcikut Do Vnhwvbqzjt	Santander	Spain
Alwvgwibp Uqm	Amsterdam	The Netherlands
Kbawruvm dtj Urcbguimowgj Mdxsawda Alz	Munich	Germany
Uxuiiouoee Dojsa Sdpls Dy Rskl Ls Sybetlse	Rome	Italy
Ifcohrzb dd Cxohywkifcoe Hkmtrajusui Uttzvqbawyhkf dx Skbvi Ejxqrzf (advceme	Saint Priest En Jarez	France
Kxcpwjndf Sugieaz Smjjhzgwvahxrip il Jjmx Pufas If	Cracow	Poland
Hrgjnlzv Ujnvuwcntuugco Spvfdnggin &yqhrtg Hmsmsba dk Hxzyhebljxq	STRASBOURG, Alsace	France
Cci Kcvxedm Bfdcdfy	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	17.05.2025
Czechia	Not recruiting	17.05.2025
France	Not recruiting	17.05.2025
Germany	Not recruiting	17.05.2025
Italy	Not recruiting	17.05.2025
Latvia	Not recruiting	17.05.2025
Poland	Not recruiting	17.05.2025
Spain	Not recruiting	17.05.2025
The Netherlands	Not recruiting	17.05.2025

Trial locations

Investigated drugs:

Mosliciguat

Mosliciguat is a medication being studied for its potential to help people with pulmonary hypertension, which is high blood pressure in the lungs, associated with interstitial lung disease. This medication works by relaxing the blood vessels in the lungs, which may help to lower the blood pressure in these vessels. The goal of using Mosliciguat in this trial is to see if it can reduce the resistance in the blood vessels of the lungs, making it easier for the heart to pump blood through them. This could potentially improve breathing and overall heart function in patients with this condition.

Pulmonary Hypertension Associated with Interstitial Lung Disease – This condition involves high blood pressure in the blood vessels of the lungs, which is linked to interstitial lung disease. It begins with damage to the lung tissue, leading to scarring and inflammation. As the lung tissue becomes more scarred, it becomes harder for blood to flow through the lungs, causing increased pressure in the pulmonary arteries. Over time, this increased pressure can strain the heart, particularly the right side, as it works harder to pump blood through the lungs. The disease progresses as the lung tissue continues to scar, further increasing the pressure in the pulmonary arteries. This can lead to symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles.

Trial ID:

2024-513991-16-00

Protocol code:

RVT-2301-201

NCT ID:

NCT06635850

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Mosliciguat for Patients with Pulmonary Hypertension Linked to Interstitial Lung Disease

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