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
NCT06274801
Where you'd take part
This study runs at 120 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
"Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic
Athens, Greeceno site contact published
Recruiting
"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department
Cluj-Napoca, Romaniano site contact published
Recruiting
A.O.U. Policlinico Umberto I
Roma, Italyno site contact published
Recruiting
Aarhus Universiteshospital
Aarhus, Denmarkno site contact published
Recruiting
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloniki, Greeceno site contact published
Recruiting
Asan Medical Center
Seoul, South Koreano site contact published
Recruiting
ATTIKON University Hospital, 2nd Critical Care Department
Athens, Greeceno site contact published
Recruiting
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Naples, Italyno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Richard Aranda, MD · STUDY_DIRECTOR · Gossamer Bio USA, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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)