Mosliciguat added to inhaled treprostinil for pulmonary hypertension from ILD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open-label, multi-center study where participants with right-heart-catheterization–confirmed pulmonary hypertension associated with interstitial lung disease receive inhaled mosliciguat while continuing background inhaled treprostinil. The core treatment period lasts 16 weeks, after which participants who complete it may continue in an open extension period. Key entry requirements include a confirming HRCT for ILD, being on inhaled treprostinil, and a 6-minute walk distance of at least 100 meters. The study focuses on safety and tolerability of the inhaled mosliciguat delivered via a dry powder inhaler in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Site
  Santa Barbara, California, United States Recruiting
• Clinical Research Site
  Torrance, California, United States Recruiting
• Clinical Research Site
  Kissimmee, Florida, United States Recruiting
• Clinical Research Site
  Chicago, Illinois, United States Recruiting
• Clinical Research Site
  Kansas City, Kansas, United States Recruiting
• Clinical Research Site
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Pulmovant
• Email: clinicaltrials@pulmovant.com
• Phone: +1-919-462-1310

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.