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A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
NCT07333183 · Pulmovant, Inc.
In plain English
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Official title
An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
About this study
This study is an open-label study with an extension.
The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks).
Participants will receive mosliciguat in the 16-week treatment period.
All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.
Eligibility criteria
Inclusion Criteria:
* Participants willing and able to provide informed consent
* Participants on inhaled treprostinil
* 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
Enrollment target: 20 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-23
Estimated completion: 2028-01
Last updated: 2026-09-02
Interventions
Drug: inhaled mosliciguatDevice: Dry Powder Inhaler
Primary outcomes
- • Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation (Baseline, Week 16)
Sponsor
Pulmovant, Inc. · industry
Contacts & investigators
ContactPulmovant · contact · clinicaltrials@pulmovant.com · +1-919-462-1310
InvestigatorUbaldo Martin, MD · study_director, Pulmovant, Inc.
All locations (13)
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Santa Barbara, California, United States
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Torrance, California, United States
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Kissimmee, Florida, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Albuquerque, New Mexico, United States
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Greensboro, North Carolina, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Houston, Texas, United States