Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

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.

NCT Number	NCT07181382
Lead Sponsor	GB002, Inc. Collaborators: Chiesi Farmaceutici S.p.A.
Conditions	Pulmonary Hypertension Associated With Interstitial Lung Disease
Enrollment	480 participants
Start Date	2026-02
Primary Completion	2028-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-19