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Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study.
Study details:
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-09-03
Primary completion: 2026-12-01
Study completion finish: 2026-12-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06274801
Intervention or treatment
DRUG: Seralutinib
DEVICE: Gereic Dry Powder Inhaler
Conditions
- • Pulmonary Arterial Hypertension
Find a site
Closest Location:
St Vincent's Hospital (Melbourne)
Research sites nearby
Select from list below to view details:
St Vincent's Hospital (Melbourne)
Fitzroy, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Seralutinib 90 mg
| DRUG: Seralutinib
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events (TEAEs) | Not Specified | From baseline to end of study (up to 48 months or availability of commercial product) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Changes in distance achieved on the Six-Minute Walk Test (6MWT) | Δ6MWT from Baseline to End of Study | Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) |
Changes in NT-proBNP | Change in NT-proBNP from Baseline to End of Study | Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) |
Frequently Asked Questions
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