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RecruitingPhase 3

A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat 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 how safe inhaled mosliciguat is and how well it works compared with a placebo, which has no active drug. It is for people with high blood pressure in the lungs linked to interstitial lung disease, which affects the tissue around the lungs’ air sacs.

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

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 have high blood pressure in the lungs linked to interstitial lung disease, confirmed by a detailed CT scan.
  • Your lung disease is idiopathic interstitial pneumonia (lung disease with no known cause), chronic hypersensitivity pneumonitis (long-term lung inflammation from an immune reaction), or lung disease linked to a connective tissue disease.
  • Your high lung blood pressure is confirmed by right heart catheterization, a test using a thin tube to measure pressure.
  • 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 (such as pulmonary arterial hypertension), Group 2 (linked to left heart disease), Group 4 (such as long-term blood clots), or Group 5 (such as an unclassified type).
  • Your lung disease worsened and needed a treatment change or hospital stay within 28 days before assignment to a study group.
  • You use more than 10 liters of extra oxygen per minute while resting.
  • You have had trouble tolerating mosliciguat or drugs called sGC stimulators or activators.
  • You started a lung rehabilitation program, or were in its early active phase, within 28 days before assignment to a study group.
  • You received an experimental treatment or treatment as part of a study too recently: within 42 days or 5 drug half-lives before group assignment, whichever is longer. A half-life is the time it takes half a drug to leave the 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 with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic Hypersensitivity pneumonitis 3. ILD associated connective tissue disease (CTD) * Confirmed pulmonary hypertension by right heart catheterization (RHC). * Ability to perform 6-minute walk distance ≥100 meters. Exclusion Criteria: * Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified). * Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization * Receiving \>10 L/min oxygen supplementation by any mode of delivery at rest * History of intolerance to mosliciguat, or sGC stimulators or activators. * Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization. * Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.

Study sites (3)

FL

KY

OR