A Study of Mosliciguat in PH-ILD

Phase 2

Recruiting

• Conditions: Pulmonary Hypertension; Interstitial Lung Disease; Lung Diseases; Vascular Diseases; Cardiovascular Diseases; Fibrosis
• Interventions: Drug: Mosliciguat; Device: Dry Powder Inhaler; Drug: Placebo

• Registration Number: NCT06635850
• Lead Sponsor: Pulmovant, Inc.

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-14
• Study Start: 2024-11
• Primary Completion: 2026-12
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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:

  1. Idiopathic interstitial pneumonia (IIP)
  2. Chronic hypersensitivity pneumonitis
  3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mosliciguat	Mosliciguat	Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Extension	Mosliciguat	After Week 24, all participants may receive mosliciguat through an Extension period
Mosliciguat	Dry Powder Inhaler	Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Matched Placebo	Dry Powder Inhaler	Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Matched Placebo	Placebo	Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Extension	Dry Powder Inhaler	After Week 24, all participants may receive mosliciguat through an Extension period

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)	Baseline, Week 16	PVR evaluated using right heart catheterization (RHC).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)	Baseline, Week 16	The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)	Baseline, Week 16	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.

Trial Locations

Locations (2)

PulmonIx; 🇺🇸 Greensboro, North Carolina, United States

Summit Health; 🇺🇸 Bend, Oregon, United States