Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
brief summary
This Phase 3 study is designed as a 24-week randomized, double-blind, placebo-controlled period (PCP) followed by a 144-week long-term extension (LTE) period. The primary objective of the PCP is to evaluate the effect of seralutinib on improving exercise capacity in subjects with World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease. The primary objective of the LTE is to evaluate the long-term safety and tolerability of seralutinib.
official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to 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