Pulmovant Study

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

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Pulmonary hypertension
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All genders
person-wave 18-80
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Overview
Principal Investigator: Harrison Farber

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.

Study details
Inclusion Criteria
  • Participants with diagnosis of Interstitial Lung Disease (ILD), Confirmed pulmonary hypertension by right heart catheterization.
  • Ability to perform 6MWD ≥100 meters.
  • Eligible diagnosis for ILD: Idiopathic interstitial pneumonia (IIP), Chronic hypersensitivity pneumonitis (CHP), ILD associated with Connective tissue disease.
Exclusion Criteria
  • Exacerbation of underlying lung disease within 28 days prior to randomization.
  • Receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  • Initiation of pulmonary rehabilitation within 28 days prior to randomization.
Study Requirements

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. There will be two right heart catheterization, two CT-scan or chest X-ray, two echocardiogram and two pulmonary function test done during double blind phase along with laboratory blood draws for safety and biomarker.