Clinical trial NCT06635850: A Study of Mosliciguat in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Hypertension
Interstitial Lung Disease
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Fibrosis
Keywords: PH
ILD
6 Minute Walk Test
mosliciguat
Lead sponsor: Pulmovant, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

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:

  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.

Primary outcomes:
measure: Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)
timeFrame: Baseline, Week 16
measure: Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis School of Medicine
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center - Torrance
state: California
city: Celebration
country: United States
facility: Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Pulmonary Specialists
state: Kentucky
city: Durham
country: United States
facility: Duke University Health System - Duke Clinic
state: North Carolina
city: Greensboro
country: United States
facility: PulmonIx
state: North Carolina
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Bend
country: United States
facility: Summit Health
state: Oregon
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine
state: Pennsylvania
city: East Providence
country: United States
facility: Brown Medicine
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Lung Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: Pulmovant, Inc.
name: Ubaldo Martin, MD
role: STUDY_DIRECTOR
References: