Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-12-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

GB002, Inc.

Collaborator:

Chiesi Farmaceutici S.p.A.