A Study of Mosliciguat in PH-ILD (PHocus)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Fibrosis; Lung Diseases; Pulmonary Hypertension; Interstitial Lung Disease
• Intervention / Treatment: Drug: Mosliciguat; Device: Dry Powder Inhaler; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Arizona Pulmonary Specialists
  • California
    • Los Angeles, California, United States, 90024
      • Ronald Reagan UCLA Medical Center
    • Sacramento, California, United States, 95817
      • University of California Davis School of Medicine
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center - Torrance
  • Florida
    • Celebration, Florida, United States, 34746
      • Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
  • Illinois
    • Chicago, Illinois, United States, 60026
      • Northwestern University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Pulmonary Specialists
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System - Duke Clinic
    • Greensboro, North Carolina, United States, 27403
      • PulmonIx
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Hoxworth Blood Center
  • Oregon
    • Bend, Oregon, United States, 97701
      • Summit Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Lewis Katz School of Medicine
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Brown Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Lung Center
  • Utah
    • Salt Lake City, Utah, United States, 84132-0001
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mosliciguat; Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks	Drug: Mosliciguat; Dose level 1, 2, or 3 for inhalation; Device: Dry Powder Inhaler; Dry powder inhaler for mosliciguat or placebo delivery
Placebo Comparator: Matched Placebo; Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks	Device: Dry Powder Inhaler; Dry powder inhaler for mosliciguat or placebo delivery; Drug: Placebo; Matching placebo for inhalation
Experimental: Extension; After Week 24, all participants may receive mosliciguat through an Extension period	Drug: Mosliciguat; Dose level 1, 2, or 3 for inhalation; Device: Dry Powder Inhaler; Dry powder inhaler for mosliciguat or placebo delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)	PVR evaluated using right heart catheterization (RHC).	Baseline, Week 16

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pulmovant, Inc.
• Investigators: Study Director: Ubaldo Martin, MD, Pulmovant, Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ILD; PH; 6 Minute Walk Test; mosliciguat
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hypertension; Pathological Conditions, Signs and Symptoms; Lung Diseases; Cardiovascular Diseases; Fibrosis; Vascular Diseases; Lung Diseases, Interstitial; Hypertension, Pulmonary; Equipment and Supplies; Nebulizers and Vaporizers; Dry Powder Inhalers
• Other Study ID Numbers: RVT-2301-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes