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

a study on High Blood Pressure Pulmonary Hypertension Interstitial Lung Disease Lung Diseases Vascular Disease Cardiovascular Disease Fibrosis

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Torrance, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Details

This study is an open-label study with an extension.

The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks).

Participants will receive mosliciguat in the 16-week treatment period.

All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.

Keywords

Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis, PH, ILD, 6 Minute Walk Test, mosliciguat, Interstitial Lung Diseases, Dry Powder Inhalers, inhaled mosliciguat, Dry Powder Inhaler, Extension: inhaled mosliciguat

Eligibility

You can join if…

Open to people ages 18-85

  • 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.

You CAN'T join 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.

Locations

  • Clinical Research Site accepting new patients
    Torrance California 90502 United States
  • Clinical Research Site accepting new patients
    Santa Barbara California 93105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pulmovant, Inc.
Links
Sign up for this study
ID
NCT07333183
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated
Contact us about this trial