Study Results
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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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2024-10-29
2028-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mosliciguat
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Mosliciguat
Dose level 1, 2, or 3 for inhalation
Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
Matched Placebo
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
Placebo
Matching placebo for inhalation
Extension
After Week 24, all participants may receive mosliciguat through an Extension period
Mosliciguat
Dose level 1, 2, or 3 for inhalation
Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
Interventions
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Mosliciguat
Dose level 1, 2, or 3 for inhalation
Dry Powder Inhaler
Dry powder inhaler for mosliciguat or placebo delivery
Placebo
Matching placebo for inhalation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Pulmovant, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ubaldo Martin, MD
Role: STUDY_DIRECTOR
Pulmovant, Inc.
Locations
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Arizona Pulmonary Specialists
Phoenix, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of California Davis School of Medicine
Sacramento, California, United States
Harbor-UCLA Medical Center - Torrance
Torrance, California, United States
Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
Celebration, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Duke University Health System - Duke Clinic
Durham, North Carolina, United States
PulmonIx
Greensboro, North Carolina, United States
Hoxworth Blood Center
Cincinnati, Ohio, United States
Summit Health
Bend, Oregon, United States
Lewis Katz School of Medicine
Philadelphia, Pennsylvania, United States
Brown Medicine
East Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Lung Center
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Lusmelys Guevara
Role: primary
Role: backup
Murali Ramaswamy, MD
Role: primary
Role: backup
Madison Cox
Role: primary
Role: backup
Related Links
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Related Info
Other Identifiers
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RVT-2301-201
Identifier Type: -
Identifier Source: org_study_id
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