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
1 other identifier
interventional
135
1 country
18
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
February 20, 2026
February 1, 2026
2.1 years
October 8, 2024
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
PVR evaluated using right heart catheterization (RHC).
Baseline, Week 16
Secondary Outcomes (2)
Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
Baseline, Week 16
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Baseline, Week 16
Study Arms (3)
Mosliciguat
ACTIVE COMPARATORParticipants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Matched Placebo
PLACEBO COMPARATORParticipants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Extension
EXPERIMENTALAfter Week 24, all participants may receive mosliciguat through an Extension period
Interventions
Dry powder inhaler for mosliciguat or placebo delivery
Eligibility Criteria
You may qualify if:
- 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:
- Idiopathic interstitial pneumonia (IIP)
- Chronic hypersensitivity pneumonitis
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pulmovant, Inc.lead
Study Sites (18)
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024, United States
University of California Davis School of Medicine
Sacramento, California, 95817, United States
Harbor-UCLA Medical Center - Torrance
Torrance, California, 90502, United States
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Celebration, Florida, 34746, United States
Northwestern University
Chicago, Illinois, 60026, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
Duke University Health System - Duke Clinic
Durham, North Carolina, 27710, United States
PulmonIx
Greensboro, North Carolina, 27403, United States
Hoxworth Blood Center
Cincinnati, Ohio, 45267, United States
Summit Health
Bend, Oregon, 97701, United States
Lewis Katz School of Medicine
Philadelphia, Pennsylvania, 19140, United States
Brown Medicine
East Providence, Rhode Island, 02915, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Houston Methodist Lung Center
Houston, Texas, 77030, United States
University of Utah Health
Salt Lake City, Utah, 84132-0001, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ubaldo Martin, MD
Pulmovant, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 10, 2024
Study Start
October 29, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
February 20, 2026
Record last verified: 2026-02