A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)

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

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

This study is a randomized double-blind placebo control study with an extension.

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 receive mosliciguat.

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.