Pulmonary Hypertension, Interstitial Lung Disease, Vascular Diseases, Cardiovascular Diseases, Fibrosis
Conditions
Keywords
PH, ILD, 6 Minute Walk Distance, mosliciguat
Brief summary
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
Detailed description
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.
Interventions
DRUGMosliciguat
Dose level 1, 2, or 3 for inhalation
DRUGPlacebo
Matching Placebo for inhalation
DEVICEDry Powder Inhaler
Administration via dry powder inhaler
Sponsors
Pulmovant, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participants willing and able to provide informed consent. * Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic Hypersensitivity pneumonitis 3. ILD associated connective tissue disease (CTD) * Confirmed pulmonary hypertension by right heart catheterization (RHC). * Ability to perform 6-minute walk distance ≥100 meters.
Exclusion criteria
* Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified). * Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization * Receiving \>10 L/min oxygen supplementation by any mode of delivery at rest * History of intolerance to mosliciguat, or sGC stimulators or activators. * Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization. * Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 6-Minute Walk Distance (6MWD) | Baseline to Week 24 | The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical Worsening (TTCW) | From randomization through Week 24 | 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 |
| Percent Change from Baseline in Pulmonary Vascular Resistance (PVR) | Baseline to Week 24 | PVR evaluated using right heart catheterization (RHC) |
| Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) | Baseline to Week 24 | 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. |
| Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score | Baseline to Week 24 | Change from baseline to Week 24 in L-PF total symptom scores (patient-reported outcome). |
Countries
United States
Contacts
CONTACTPulmovant Inc
STUDY_DIRECTORUbaldo Martin
Pulmovant, Inc.
Outcome results
None listed