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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase 2, open-label, 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) on a background inhaled treprostinil.

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

• 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:

‣ Idiopathic interstitial pneumonia (IIP)

⁃ Chronic hypersensitivity pneumonitis

⁃ 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.

Locations
United States
Florida
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
RECRUITING
Kissimmee
Contact Information
Primary
Pulmovant
clinicaltrials@pulmovant.com
+1-919-462-1310
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2028-01
Participants
Target number of participants: 20
Treatments
Experimental: Active Comparator: inhaled mosliciguat
Participants will receive inhaled mosliciguat daily for 16 weeks
Experimental: Extension: inhaled mosliciguat
After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period
Sponsors
Leads: Pulmovant, Inc.

This content was sourced from clinicaltrials.gov