A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

Pulmovant, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Lung Diseases; Interstitial Lung Disease (ILD); Cardiovascular Diseases; Fibrosis; Vascular Diseases; Pulmonary Hypertension

Treatments: Device: Dry Powder Inhaler; Drug: inhaled mosliciguat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07333183

RVT-2301-202

Details and patient eligibility

About

This is a Phase 2, open-label, 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) on a background inhaled treprostinil.

Full description

This study is an open-label study with an extension.

The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks).

Participants will receive mosliciguat in the 16-week treatment period.

All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants willing and able to provide informed consent

• Participants on inhaled treprostinil

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Active Comparator: inhaled mosliciguat

Experimental group

Description:

Participants will receive inhaled mosliciguat daily for 16 weeks

Treatment:

Device: Dry Powder Inhaler

Drug: inhaled mosliciguat

Extension: inhaled mosliciguat

Experimental group

Description:

After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period

Treatment:

Device: Dry Powder Inhaler

Drug: inhaled mosliciguat