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A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Participants willing and able to provide informed consent.

• Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:

‣ Idiopathic interstitial pneumonia (IIP)

⁃ Chronic Hypersensitivity pneumonitis

⁃ ILD associated connective tissue disease (CTD)

• Confirmed pulmonary hypertension by right heart catheterization (RHC).

• Ability to perform 6-minute walk distance ≥100 meters.

Locations
United States
Florida
Clinical Research Site
RECRUITING
Kissimmee
Kentucky
Clinical Research Site
RECRUITING
Louisville
Oregon
Clinical Research Site
RECRUITING
Bend
Contact Information
Primary
Pulmovant Inc
clinicaltrials@pulmovant.com
+1-919-462-1310
Time Frame
Start Date: 2026-08-31
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 376
Treatments
Active_comparator: Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Placebo_comparator: Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Experimental: Extension
After Week 24, all participants may receive mosliciguat through an Extension period
Sponsors
Leads: Pulmovant, Inc.

This content was sourced from clinicaltrials.gov

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