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: 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: 80
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
RECRUITING
Phoenix
California
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
University of California Davis School of Medicine
RECRUITING
Sacramento
Harbor-UCLA Medical Center - Torrance
RECRUITING
Torrance
Florida
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
RECRUITING
Celebration
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
Norton Pulmonary Specialists
RECRUITING
Louisville
North Carolina
Duke University Health System - Duke Clinic
RECRUITING
Durham
PulmonIx
RECRUITING
Greensboro
Ohio
Hoxworth Blood Center
RECRUITING
Cincinnati
Oregon
Summit Health
RECRUITING
Bend
Pennsylvania
Lewis Katz School of Medicine
RECRUITING
Philadelphia
Rhode Island
Brown Medicine
RECRUITING
East Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Houston Methodist Lung Center
RECRUITING
Houston
Utah
University of Utah Health
RECRUITING
Salt Lake City
Contact Information
Primary
Pulmovant
clinicaltrials@pulmovant.com
+1-919-462-1310
Time Frame
Start Date:2024-10-29
Estimated Completion Date:2028-01
Participants
Target number of participants:120
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