Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

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 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease. The study has a 24-week blinded period followed by an extension in which all participants may receive mosliciguat. Participants are randomized to mosliciguat or placebo during the blinded period, and those who complete it may enter the extension where mosliciguat is given to all. The trial uses a dry powder inhaler and assesses outcomes such as functional capacity and other clinical measures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Site
  Kissimmee, Florida, United States Recruiting
• Clinical Research Site
  Louisville, Kentucky, United States Recruiting
• Clinical Research Site
  Bend, Oregon, United States Recruiting

Study contacts

• Study coordinator: Pulmovant Inc
• 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.