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RecruitingPhase 2

A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of inhaled mosliciguat when added to inhaled treprostinil and how well people tolerate it. It is for people with high blood pressure in the lungs linked to interstitial lung disease, which causes lung scarring or inflammation. Other rules for joining may apply.

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are willing and able to give informed consent, meaning you understand the study and agree to join.
  • You are taking inhaled treprostinil.
  • A detailed CT scan confirms interstitial lung disease with widespread lung changes.
  • You have an eligible lung disease: idiopathic interstitial pneumonia (lung disease with no known cause), chronic hypersensitivity pneumonitis (long-term lung inflammation from inhaled substances), or lung disease linked to a connective tissue disease.
  • If your lung disease is linked to a connective tissue disease, your FVC (the amount of air you can forcefully breathe out) must be below 70% of the expected amount.
  • A right heart catheter test, which uses a thin tube to measure pressure, confirms high blood pressure in your lungs.
  • You can walk at least 100 meters in 6 minutes.

Who can't join

  • You have another type of high lung blood pressure: Group 1 (including pulmonary arterial hypertension), Group 2 (linked to left-heart problems), Group 4 (including long-term blood clots), or Group 5 (other or unclassified causes).
  • Your lung disease flared up within 28 days before study group assignment.
  • You started a lung exercise and training program within 28 days before study group assignment.
  • You need more than 10 liters of extra oxygen per minute while resting at the start of the study.
  • You have used mosliciguat or drugs called sGC stimulators or activators before, could not tolerate them, or they did not work for you.
  • You received an experimental treatment within 42 days before study group assignment, or within 5 half-lives (five times the time it takes half the drug to leave your body).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants willing and able to provide informed consent * Participants on inhaled treprostinil * Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic hypersensitivity pneumonitis 3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) \< 70% of predicted * Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC). * Ability to perform 6MWD ≥100 meters. Exclusion Criteria: * Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified). * Exacerbation of underlying lung disease within 28 days prior to randomization. * Initiation of pulmonary rehabilitation within 28 days prior to randomization. * Receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. * History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators. * Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization. Note: Other inclusion and exclusion criteria may apply.

Study sites (13)

CA

FL

IL

KS

MA

MI

NC

NM

RI

SC

TX