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A Study of Mosliciguat in PH-ILD

Active Not RecruitingPhase 2

Sponsor: Pulmovant, Inc.

Conditions: Pulmonary Hypertension, Interstitial Lung Disease, Lung Diseases, Vascular Diseases, Cardiovascular Diseases

Interventions: Mosliciguat, Dry Powder Inhaler, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 one of the following:

  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 6MWT ≥100 meters.

Exclusion Criteria:

* Diagnosis of WHO 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 requiring augmentation of therapy or emergent hospitalization 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.

Locations (85)

Phoenix, Arizona, United States
Los Angeles, California, United States
Sacramento, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Washington D.C., District of Columbia, United States
Celebration, Florida, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Bend, Oregon, United States
Philadelphia, Pennsylvania, United States
East Providence, Rhode Island, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Santa Fe, Argentina
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
Auchenflower, Queensland, Australia
+ 55 more on CT.gov