A Study of Mosliciguat in PH-ILD

Purpose

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Conditions

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants willing and able to provide informed consent - 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.

Study Design

Phase
Phase 2
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
    Dry powder inhaler for mosliciguat or placebo delivery
Placebo Comparator
Matched Placebo 		Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
  • Device: Dry Powder Inhaler
    Dry powder inhaler for mosliciguat or placebo delivery
  • Drug: Placebo
    Matching placebo for inhalation
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
    Dry powder inhaler for mosliciguat or placebo delivery

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Crystal Billings
913-588-2817
cbillings4@kumc.edu

More Details

Status
Recruiting
Sponsor
Pulmovant, Inc.

Study Contact

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

Detailed Description

This study is a randomized, double-blind, placebo-controlled 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 will receive mosliciguat.