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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Comparator: inhaled mosliciguat

Participants will receive inhaled mosliciguat daily for 16 weeks

Group Type EXPERIMENTAL

inhaled mosliciguat

Intervention Type DRUG

Dose level 1, 2, or 3 for inhalation

Dry Powder Inhaler

Intervention Type DEVICE

Dry powder inhaler for mosliciguat delivery

Extension: inhaled mosliciguat

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

Group Type EXPERIMENTAL

inhaled mosliciguat

Intervention Type DRUG

Dose level 1, 2, or 3 for inhalation

Dry Powder Inhaler

Intervention Type DEVICE

Dry powder inhaler for mosliciguat delivery

Interventions

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inhaled mosliciguat

Dose level 1, 2, or 3 for inhalation

Intervention Type DRUG

Dry Powder Inhaler

Dry powder inhaler for mosliciguat delivery

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No