A Study of Mosliciguat in PH-ILD (PHocus)

Pulmovant, Inc.

Status and phase: Enrolling; Phase 2

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

Treatments: Device: Dry Powder Inhaler; Drug: Mosliciguat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06635850

RVT-2301-201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Mosliciguat

Active Comparator group

Description:

Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks

Treatment:

Drug: Mosliciguat

Device: Dry Powder Inhaler

Matched Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks

Treatment:

Drug: Placebo

Device: Dry Powder Inhaler

Extension

Experimental group

Description:

After Week 24, all participants may receive mosliciguat through an Extension period

Treatment:

Drug: Mosliciguat

Device: Dry Powder Inhaler