NCT04456998

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

Conditions

• Pulmonary Artery Hypertension

Interventions

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

Timeline

• Start date: 2020-11-12
• Primary completion: 2022-10-17
• Completion: 2022-11-01
• First posted: 2020-07-07
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

63 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Serbia, Spain, United Kingdom

Regulatory

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