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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506334-75-00

Acronym

GB002-3102

Enrollment

128

Registered

2024-06-18

Start date

2024-07-12

Completion date

Unknown

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief summary

Incidence of treatment-emergent adverse events (TEAEs)

Detailed description

1. Changes in distance achieved on the six-minute walk test (6MWT), (Δ6MWD), 2. Changes in NT-proBNP

Interventions

DRUGGB002

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs)	—

Secondary

Measure	Time frame
1. Changes in distance achieved on the six-minute walk test (6MWT), (Δ6MWD), 2. Changes in NT-proBNP	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026