GB002-3201_SERANATA - Clinical Trial
¿Cuál es el Propósito de este estudio?
This study is a big test to see if a new medicine works. It is called a Phase 3 trial. People in the study will be put into groups by chance. One group will get a fake medicine called a placebo, and the other group will get the real medicine. The real medicine is named Seralutinib. It is breathed in two times every day.
The study will last for 30 weeks. After that, people can keep taking part for up to two more years. During the study, doctors will do tests like blood draws, heart checks, breathing tests, and pictures of the chest. They will also check how far you can walk in six minutes. There will be 11 visits in the first 30 weeks.
Pulmonary Hypertension is a problem where the blood pressure in the lungs becomes too high. It can happen to people who already have Interstitial Lung Disease, which means their lungs are damaged or scarred. Doctors find out if someone has this problem by using special tests like an echocardiogram or a right heart catheterization.
¿Quién puede participar en el Estudio?
-Age > 18
-Diagnosis of ILD of any kind (IPF, ILD associated with autoimmune disease)
- Diagnosis of PH based on right heart catheterization data
- allowed to be on treatment with anti-fibrotic and immune suppressive agents
- allowed to be on inhaled Tyvaso
- less than 10LPM supplemental oxygen at rest
¿Qué Implica?
This study is a special test to see if a new medicine called Seralutinib can help people who have a lung problem called pulmonary hypertension. This problem makes it hard to breathe and walk. The test will check if the medicine helps people walk farther and feel less short of breath. Right now, there is only one medicine for this illness, and it is hard for people to use. If Seralutinib works, it could give doctors another choice to help patients feel better.
Detalles del Estudio
