Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
376 (estimated)
Sponsor
Pulmovant, Inc. · Industry
Who this trial is looking for
This trial is looking for people with pulmonary hypertension related to lung disease. Participants will take inhaled Mosliciguat and be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am willing and able to provide informed consent.
I have been diagnosed with pulmonary hypertension related to lung disease.
I have a confirmed diagnosis through a specific lung scan.
I can walk at least 100 meters in 6 minutes.
You may not be able to join if
I have pulmonary hypertension from other specific groups.
I have had a worsening of my lung disease that required treatment or hospital stay in the last 28 days.
I use more than 10 liters of oxygen per minute while resting.
I have a history of not tolerating Mosliciguat or similar drugs.
I have started pulmonary rehabilitation or am currently in that program within the last 28 days.
I have received experimental treatment in the last 42 days or since my last medication half-life.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants willing and able to provide informed consent.
* Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenc…
Inclusion Criteria:
* Participants willing and able to provide informed consent.
* Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:
1. Idiopathic interstitial pneumonia (IIP)
2. Chronic Hypersensitivity pneumonitis
3. ILD associated connective tissue disease (CTD)
* Confirmed pulmonary hypertension by right heart catheterization (RHC).
* Ability to perform 6-minute walk distance ≥100 meters.
Exclusion Criteria:
* Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
* Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization
* Receiving \>10 L/min oxygen supplementation by any mode of delivery at rest
* History of intolerance to mosliciguat, or sGC stimulators or activators.
* Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization.
* Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.
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