A Study of Mosliciguat in PH-ILD

Description

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).

Conditions

Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis

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Study Overview

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Study Details

Study overview

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).

A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

A Study of Mosliciguat in PH-ILD

Condition
Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

Greensboro

PulmonIx, Greensboro, North Carolina, United States, 27403

Bend

Summit Health, Bend, Oregon, United States, 97701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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:
  • 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pulmovant, Inc.,

Sudhir Penugonda, MD, STUDY_DIRECTOR, Pulmovant, Inc.

Study Record Dates

2028-01