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Stimulator of Soluble Guanylate Cyclase

Mosliciguat for Pulmonary Hypertension (PHocus Trial)

Phase 2
Recruiting
Research Sponsored by Pulmovant, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to perform 6MWD ≥100 meters
Participants with diagnosis of Interstitial Lung Disease (ILD) confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease, including Idiopathic interstitial pneumonia (IIP), Chronic hypersensitivity pneumonitis, ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) < 70% of predicted
Must not have
History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators
Exacerbation of underlying lung disease within 28 days prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 16

Summary

This trial will test the safety and effectiveness of inhaled mosliciguat in people with high blood pressure in the lungs caused by lung disease.

Who is the study for?
This trial is for people with a condition where high blood pressure in the lungs is caused by scarring or inflammation of lung tissue (PH-ILD). Participants should have this specific type of lung and heart issue but not be dealing with other major health problems that could interfere with the study.
What is being tested?
The study tests mosliciguat, a new treatment delivered through an inhaler, against a placebo (a substance with no active drug) to see if it's safe and effective for PH-ILD. People will be randomly assigned to either get mosliciguat or the placebo without knowing which one they receive.
What are the potential side effects?
Possible side effects from mosliciguat may include irritation in the respiratory tract, headaches, dizziness, gastrointestinal discomforts like nausea or diarrhea, and potential risks associated with lowering blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk 100 meters or more without stopping.
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I have a lung condition diagnosed by a CT scan with less than 70% normal lung function.
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My pulmonary hypertension was confirmed by a heart catheter test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bad reaction or no improvement with mosliciguat or similar medications.
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My lung condition hasn't worsened in the last 28 days.
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I have been diagnosed with a specific type of pulmonary hypertension.
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I need more than 10 liters per minute of oxygen at rest.
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I haven't taken any experimental drugs in the last 42 days or 5 half-lives.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)
Secondary study objectives
Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Change from Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ExtensionExperimental Treatment2 Interventions
After Week 24, all participants may receive mosliciguat through an Extension period
Group II: MosliciguatActive Control2 Interventions
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Group III: Matched PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dry Powder Inhaler
2015
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Pulmovant, Inc.Lead Sponsor
Sudhir Penugonda, MDStudy DirectorPulmovant, Inc.
~80 spots leftby Dec 2026
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