Acute Interstitial Pneumonia Clinical Trials

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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
Location: See all (18) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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).

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 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
Arizona
Arizona Pulmonary Specialists
Phoenix
California
Ronald Reagan UCLA Medical Center
Los Angeles
University of California Davis School of Medicine
Sacramento
Harbor-UCLA Medical Center - Torrance
Torrance
Florida
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Celebration
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Northwestern University
Chicago
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Norton Pulmonary Specialists
Louisville
North Carolina
Duke University Health System - Duke Clinic
Durham
PulmonIx
Greensboro
Ohio
Hoxworth Blood Center
Cincinnati
Oregon
Summit Health
Bend
Pennsylvania
Lewis Katz School of Medicine
Philadelphia
Rhode Island
Brown Medicine
East Providence
South Carolina
Medical University of South Carolina
Charleston
Texas
Houston Methodist Lung Center
Houston
Utah
University of Utah Health
Salt Lake City
Time Frame
Start Date: 2024-10-29
Completion Date: 2028-01
Participants
Target number of participants: 135
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