NCT07181382

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

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

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: GB002, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension Associated With Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Placebo	Matching capsule containing placebo
DRUG	Seralutinib	Capsule containing seralutinib
DEVICE	Generic Dry Powder Inhaler	Generic dry powder inhaler for seralutinib or placebo delivery

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-18
• Last updated: 2026-03-19

Locations

4 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study