A Study of Mosliciguat in PH-ILD
Purpose
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).
Conditions
- Pulmonary Hypertension
- Interstitial Lung Disease
- Lung Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Fibrosis
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Mosliciguat |
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
|
|
Placebo Comparator Matched Placebo |
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks |
|
|
Experimental Extension |
After Week 24, all participants may receive mosliciguat through an Extension period |
|
Recruiting Locations
Arizona Pulmonary Specialists
Phoenix 5308655, Arizona 5551752 85012
Phoenix 5308655, Arizona 5551752 85012
Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90024
Los Angeles 5368361, California 5332921 90024
University of California Davis School of Medicine
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
Harbor-UCLA Medical Center - Torrance
Torrance 5403022, California 5332921 90502
Torrance 5403022, California 5332921 90502
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Celebration 4150394, Florida 4155751 34746
Celebration 4150394, Florida 4155751 34746
Contact:
Lusmelys Guevara
Lusmelys Guevara
Northwestern University
Chicago 4887398, Illinois 4896861 60026
Chicago 4887398, Illinois 4896861 60026
University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Norton Pulmonary Specialists
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
Duke University Health System - Duke Clinic
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
PulmonIx
Greensboro 4469146, North Carolina 4482348 27403
Greensboro 4469146, North Carolina 4482348 27403
Contact:
Murali Ramaswamy, MD
Murali Ramaswamy, MD
Hoxworth Blood Center
Cincinnati 4508722, Ohio 5165418 45267
Cincinnati 4508722, Ohio 5165418 45267
Summit Health
Bend 5713587, Oregon 5744337 97701
Bend 5713587, Oregon 5744337 97701
Contact:
Madison Cox
Madison Cox
Lewis Katz School of Medicine
Philadelphia 4560349, Pennsylvania 6254927 19140
Philadelphia 4560349, Pennsylvania 6254927 19140
Brown Medicine
East Providence 5221931, Rhode Island 5224323 02915
East Providence 5221931, Rhode Island 5224323 02915
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
Houston Methodist Lung Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Utah Health
Salt Lake City 5780993, Utah 5549030 84132-0001
Salt Lake City 5780993, Utah 5549030 84132-0001
More Details
- NCT ID
- NCT06635850
- Status
- Recruiting
- Sponsor
- Pulmovant, Inc.
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.