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NCT06274801Not yet recruiting

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)
GB002, Inc.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Seralutinib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GB002, Inc.
Funder
Gossamer Bio Inc.
Location
Kansas City,Richmond, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Jun 01, 2024
End date
Dec 01, 2026
Enrollment
300 participants
Primary outcome

Incidence of treatment-emergent adverse events (TEAEs)

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

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06274801
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06274801 through Pure Global AI's free database. This Phase 3 trial is sponsored by GB002, Inc. and is currently Not yet recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.