Purpose of this Study
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.
Who Can Participate?
Eligibility
-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
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Followed by a Long-Term Extension Evaluating Safety and Efficacy
GB002-3201 (SERANATA)
GB002-3201 (SERANATA)
Principal Investigator
Julie
Fried
Protocol Number
PRO00118940
NCT ID
NCT07181382
Phase
III
Enrollment Status
Pending Open to Enrollment