A Study of Mosliciguat 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 18-80 (full criteria)
Location
at UC Davis UCLA
Dates
study started
study ends around

Description

Summary

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).

Official Title

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

Details

This study is a randomized, double-blind, placebo-controlled study with an extension.

The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).

Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.

All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat.

Keywords

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

Eligibility

You can join if…

Open to people ages 18-80

  • 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.

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

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90024 United States
  • University of California Davis School of Medicine accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • Harbor-UCLA Medical Center - Torrance accepting new patients
    Torrance 5403022 California 5332921 90502 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pulmovant, Inc.
Links
Related Info
ID
NCT06635850
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated