NCT04816604

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	GB002 (seralutinib)	Capsule containing GB002 (seralutinib)
DEVICE	Generic Dry Powder Inhaler	Generic dry powder inhaler for GB002 (seralutinib) delivery

Timeline

• Start date: 2021-04-05
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-03-25
• Last updated: 2026-04-09

Locations

28 sites across 7 countries: United States, Australia, Czechia, France, Germany, Spain, United Kingdom

Regulatory

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