NCT06635850

A Study of Mosliciguat in 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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Pulmovant, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Mosliciguat	Dose level 1, 2, or 3 for inhalation
DEVICE	Dry Powder Inhaler	Dry powder inhaler for mosliciguat or placebo delivery
DRUG	Placebo	Matching placebo for inhalation

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-12-01
• Completion: 2028-01-01
• First posted: 2024-10-10
• Last updated: 2026-02-20

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study