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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Dose level 1, 2, or 3 for inhalation
Dry powder inhaler for mosliciguat or placebo delivery
Matching placebo for inhalation
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
RECRUITINGChange from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
PVR evaluated using right heart catheterization (RHC).
Time frame: Baseline, Week 16
Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Time frame: Baseline, Week 16
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The NT-proBNP serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 16.
Time frame: Baseline, Week 16
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Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California Davis School of Medicine
Sacramento, California, United States
RECRUITINGHarbor-UCLA Medical Center - Torrance
Torrance, California, United States
RECRUITINGFlorida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Celebration, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGNorton Pulmonary Specialists
Louisville, Kentucky, United States
RECRUITINGDuke University Health System - Duke Clinic
Durham, North Carolina, United States
RECRUITING...and 8 more locations