NCT06274801

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: GB002, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Detailed description

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Seralutinib	Capsule containing seralutinib
DEVICE	Gereic Dry Powder Inhaler	Generic dry powder inhaler for seralutinib delivery

Timeline

• Start date: 2024-09-03
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-23
• Last updated: 2026-02-09

Locations

115 sites across 30 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study