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A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)

ConditionsPulmonary HypertensionInterstitial Lung DiseaseVascular DiseasesCardiovascular DiseasesFibrosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPulmovant, Inc.

About this trial

A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants willing and able to provide informed consent.

Idiopathic interstitial pneumonia (IIP)

Chronic Hypersensitivity pneumonitis

ILD associated connective tissue disease (CTD)

Disqualifiers

Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).

Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization

Receiving >10 L/min oxygen supplementation by any mode of delivery at rest

History of intolerance to mosliciguat, or sGC stimulators or activators.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mosliciguat

    Drug

    Dose level 1, 2, or 3 for inhalation

  • Placebo

    Drug

    Matching Placebo for inhalation

  • Dry Powder Inhaler

    Device

    Administration via dry powder inhaler

Treatment groups

376 Participants
are divided into 3 treatment groups
Group A: MosliciguatActive comparator 2 interventions
Group B: Matched PlaceboPlacebo comparator 2 interventions
Group C: ExtensionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in 6-Minute Walk Distance (6MWD)

The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes

Time frame
Baseline to Week 24

Secondary outcomes

1

Time to Clinical Worsening (TTCW)

Time from randomization to first occurrence of any of the following events as adjudicated by the independent Event Adjudication Committee (EAC). 1. Hospitalization \>24 hours due to a cardiopulmonary indication 2. Decrease in 6MWD \>15% from baseline directly related to PH-ILD, at two consecutive visits on a different day but no more than 7 days apart 3. Death (all causes) 4. Lung transplantation for worsening PH (except when pre-planned prior to the trial) 5. Need to initiate additional therapeutic intervention for the treatment of PH

Time frame
From randomization through Week 24
2

Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)

PVR evaluated using right heart catheterization (RHC)

Time frame
Baseline to Week 24
3

Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)

The NT-ProBNP serum concentrations is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 24.

Time frame
Baseline to Week 24
4

Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score

Change from baseline to Week 24 in L-PF total symptom scores (patient-reported outcome).

Time frame
Baseline to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pulmovant, Inc.

Lead sponsor

Source ClinicalTrials.gov
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