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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513991-16-00
Acronym
RVT-2301-201
Enrollment
96
Registered
2024-12-11
Start date
2025-01-17
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension Associated with Interstitial Lung Disease

Brief summary

Percent change from baseline in PVR assessed at estimated peak exposure at Week 16 (%ΔPVR16) by right heart catheterization (RHC)

Detailed description

1. Change in 6MWD from baseline measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT), 2. Change from baseline in NT-proBNP at Week 16

Interventions

DRUGColorless
DRUGclear
DRUGhard capsules for inhalation

Sponsors

Pulmovant Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change from baseline in PVR assessed at estimated peak exposure at Week 16 (%ΔPVR16) by right heart catheterization (RHC)

Secondary

MeasureTime frame
1. Change in 6MWD from baseline measured at estimated peak exposure at Week 16 using the 6-Minute Walk Test (6MWT), 2. Change from baseline in NT-proBNP at Week 16

Countries

Belgium, Czechia, France, Germany, Italy, Latvia, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026