A Study of Mosliciguat in PH-ILD

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis

In brief

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Key facts

Study ID

NCT06635850

Run by

Pulmovant, Inc.

People needed

135

Starts

2024-10-29

Expected to finish

2028-01-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants willing and able to provide informed consent
• 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:
• Idiopathic interstitial pneumonia (IIP)
• Chronic hypersensitivity pneumonitis
• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Pulmonary Specialists — Phoenix, Arizona, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• University of California Davis School of Medicine — Sacramento, California, United States
• Harbor-UCLA Medical Center - Torrance — Torrance, California, United States
• Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC — Celebration, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Pulmonary Specialists — Louisville, Kentucky, United States
• Duke University Health System - Duke Clinic — Durham, North Carolina, United States
• PulmonIx — Greensboro, North Carolina, United States
• Hoxworth Blood Center — Cincinnati, Ohio, United States
• Summit Health — Bend, Oregon, United States
• Lewis Katz School of Medicine — Philadelphia, Pennsylvania, United States
• Brown Medicine — East Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Houston Methodist Lung Center — Houston, Texas, United States
• University of Utah Health — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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