Extension Study of Seralutinib for Pulmonary Arterial Hypertension (PAH)
This study, called PROSERA-EXT, is an open-label extension study looking at the long-term safety and how well orally inhaled seralutinib works for adults with Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. You can join if you are between 18 and 75 years old and have already completed a previous study with seralutinib. The main goal is to track any side effects that happen while taking seralutinib. This study plans to enroll about 330 people and will continue until seralutinib is approved for sale or the study ends.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving seralutinib. It plans to include about 330 participants.
- What's involved
- You would take seralutinib using a dry powder inhaler. The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects from when you start treatment until the end of the study, which could be up to 48 months or until the commercial product is available.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
At a glance
Conditions
Where it's being run
120 sites across 48 statesStudy leadership
- Richard Aranda, MD · STUDY_DIRECTOR · Gossamer Bio USA, Inc.
Who to contact
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What this trial measures
- Incidence of treatment-emergent adverse events (TEAEs)From baseline to end of study (up to 48 months or availability of commercial product)