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NCT05934526Not yet recruiting

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
GB002, Inc.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Placebo
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GB002, Inc.
Funder
Gossamer Bio Inc.
Location
Kansas City, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Sep 30, 2023
End date
Oct 01, 2025
Enrollment
350 participants
Primary outcome

Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24

Summary

The primary objective of the study is to determine the effect of seralutinib on improving
 exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
 objective for this trial is to determine time to clinical worsening.

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
NCT05934526
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05934526 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 350 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.