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Clinical Trials in the USA / NCT06635850
Active, not recruiting Phase 2

A Study of Mosliciguat in PH-ILD

NCT06635850 · tracked via the Priya Life Science USA tracker
Sponsor
Pulmovant, Inc.
Phase
Phase 2
Started
2024-10-29
Last updated
2026-09-10

Condition(s) studied

Pulmonary HypertensionInterstitial Lung DiseaseLung DiseasesVascular DiseasesCardiovascular DiseasesFibrosis

Investigational drug(s) / intervention(s)

MosliciguatDry Powder InhalerPlacebo

Mosliciguat: Dose level 1, 2, or 3 for inhalation

Dry Powder Inhaler: Dry powder inhaler for mosliciguat or placebo delivery

Placebo: Matching placebo for inhalation

Study summary

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

Sex
ALL
Min age
18 Years
Max age
85 Years
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 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.

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
Clinical Research Site Phoenix Arizona
Clinical Research Site Los Angeles California
Clinical Research Site Sacramento California
Clinical Research Site Santa Barbara California
Clinical Research Site Torrance California
Clinical Research Site Washington D.C. District of Columbia
Clinical Research Site Celebration Florida
Clinical Research Site Chicago Illinois
Clinical Research Site Iowa City Iowa
Clinical Research Site Kansas City Kansas
Clinical Research Site Louisville Kentucky
Clinical Research Site Boston Massachusetts
Clinical Research Site Boston Massachusetts
Clinical Research Site New York New York
Clinical Research Site New York New York
Clinical Research Site Durham North Carolina
Clinical Research Site Greensboro North Carolina
Clinical Research Site Cincinnati Ohio
Clinical Research Site Bend Oregon
Clinical Research Site Philadelphia Pennsylvania
Clinical Research Site East Providence Rhode Island
Clinical Research Site Charleston South Carolina
Clinical Research Site Dallas Texas
Clinical Research Site Houston Texas
Clinical Research Site Salt Lake City Utah
Clinical Research Site Ciudad Autónoma de Buenos Aires Buenos Aires
Clinical Research Site Santa Fe Argentina
Clinical Research Site Sydney New South Wales
Clinical Research Site Westmead New South Wales
Clinical Research Site Auchenflower Queensland
Clinical Research Site Brussels Brussels Capital
Clinical Research Site Leuven Flanders
Clinical Research Site Porto Alegre Rio Grande do Sul
Clinical Research Site Blumenau Santa Catarina
Clinical Research Site São Paulo Brazil
Clinical Research Site São Paulo Brazil
Clinical Research Site Calgary Alberta
Clinical Research Site London Ontario
Clinical Research Site Toronto Ontario
Clinical Research Site Prague Prague

+ 45 more sites — see the full list on the official registry below.

More Pulmovant, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06635850 on ClinicalTrials.gov ↗ ← All trials in the USA