RECRUITING

A Study of Mosliciguat in PH-ILD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Quick Facts

Study Start:2024-11
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06635850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants willing and able to provide informed consent
  2. * 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:
  3. 1. Idiopathic interstitial pneumonia (IIP)
  4. 2. Chronic hypersensitivity pneumonitis
  5. 3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) \< 70% of predicted
  6. * Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
  7. * Ability to perform 6MWD ≥100 meters.
  1. * 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).
  2. * Exacerbation of underlying lung disease within 28 days prior to randomization.
  3. * Initiation of pulmonary rehabilitation within 28 days prior to randomization.
  4. * Receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  5. * History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
  6. * Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.

Contacts and Locations

Study Contact

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

Principal Investigator

Sudhir Penugonda, MD
STUDY_DIRECTOR
Pulmovant, Inc.

Study Locations (Sites)

PulmonIx
Greensboro, North Carolina, 27403
United States
Summit Health
Bend, Oregon, 97701
United States

Collaborators and Investigators

Sponsor: Pulmovant, Inc.

  • Sudhir Penugonda, MD, STUDY_DIRECTOR, Pulmovant, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-11
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • PH
  • ILD
  • 6 Minute Walk Test
  • mosliciguat

Additional Relevant MeSH Terms

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