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

Part of paid clinical trials in Kissimmee, Florida.

Sponsor
Pulmovant, Inc.
Study ID
NCT07816185
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

First listed
Sep 11, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Jan 28, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Mosliciguat
    Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
  • Placebo Comparator: Matched Placebo
    Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks
  • Experimental: Extension
    After Week 24, all participants may receive mosliciguat through an Extension period

Primary Outcome Measure

Change from Baseline in 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline to Week 24 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Research SiteKissimmeeFlorida34746
Clinical Site
Clinical Research SiteLouisvilleKentucky40202
Clinical Site
Clinical Research SiteBendOregon97701
Clinical Site

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