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
This study is a randomized double-blind placebo control 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 receive mosliciguat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
376
Dose level 1, 2, or 3 for inhalation
Matching Placebo for inhalation
Administration via dry powder inhaler
Clinical Research Site
Kissimmee, Florida, United States
RECRUITINGClinical Research Site
Louisville, Kentucky, United States
RECRUITINGClinical Research Site
Bend, Oregon, United States
RECRUITINGChange from Baseline in 6-Minute Walk Distance (6MWD)
The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes
Time frame: Baseline to Week 24
Time to Clinical Worsening (TTCW)
Time from randomization to first occurrence of any of the following events as adjudicated by the independent Event Adjudication Committee (EAC). 1. Hospitalization \>24 hours due to a cardiopulmonary indication 2. Decrease in 6MWD \>15% from baseline directly related to PH-ILD, at two consecutive visits on a different day but no more than 7 days apart 3. Death (all causes) 4. Lung transplantation for worsening PH (except when pre-planned prior to the trial) 5. Need to initiate additional therapeutic intervention for the treatment of PH
Time frame: From randomization through Week 24
Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)
PVR evaluated using right heart catheterization (RHC)
Time frame: Baseline to Week 24
Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
The NT-ProBNP serum concentrations 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 24.
Time frame: Baseline to Week 24
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score
Change from baseline to Week 24 in L-PF total symptom scores (patient-reported outcome).
Time frame: Baseline to Week 24
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