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
Overview
- Phase
- Phase 2
- Intervention
- Mosliciguat
- Conditions
- Pulmonary Hypertension
- Sponsor
- Pulmovant, Inc.
- Enrollment
- 135
- Locations
- 18
- Primary Endpoint
- Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
- •Exacerbation of underlying lung disease within 28 days prior to randomization.
- •Initiation of pulmonary rehabilitation within 28 days prior to randomization.
- •Receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
- •History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
- •Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.
- •Note: Other inclusion and exclusion criteria may apply.
Arms & Interventions
Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Intervention: Mosliciguat
Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Intervention: Dry Powder Inhaler
Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Intervention: Dry Powder Inhaler
Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Intervention: Placebo
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
Intervention: Mosliciguat
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
Intervention: Dry Powder Inhaler
Outcomes
Primary Outcomes
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
Time Frame: Baseline, Week 16
PVR evaluated using right heart catheterization (RHC).
Secondary Outcomes
- Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)(Baseline, Week 16)
- Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)(Baseline, Week 16)