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

Purpose

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

Conditions

  • Pulmonary Hypertension
  • Interstitial Lung Disease
  • Vascular Diseases
  • Cardiovascular Diseases
  • Fibrosis

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Mosliciguat 		Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
  • Drug: Mosliciguat
    Dose level 1, 2, or 3 for inhalation
  • Device: Dry Powder Inhaler
    Administration via dry powder inhaler
Placebo Comparator
Matched Placebo 		Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
  • Drug: Placebo
    Matching Placebo for inhalation
  • Device: Dry Powder Inhaler
    Administration via dry powder inhaler
Experimental
Extension 		After Week 24, all participants may receive mosliciguat through an Extension period
  • Drug: Mosliciguat
    Dose level 1, 2, or 3 for inhalation
  • Device: Dry Powder Inhaler
    Administration via dry powder inhaler

Recruiting Locations

Clinical Research Site
Kissimmee, Florida 34746
Contact:
Clinical Site

Clinical Research Site
Louisville, Kentucky 40202
Contact:
Clinical Site

Clinical Research Site
Bend, Oregon 97701
Contact:
Clinical Site

More Details

Status
Recruiting
Sponsor
Pulmovant, Inc.

Study Contact

Pulmovant Inc
+1-919-462-1310
clinicaltrials@pulmovant.com

Detailed Description

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.