Pure Global

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) - Trial NCT05934526

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT05934526
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05934526
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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)

Study Focus

Placebo

Interventional

drug

Sponsor & Location

GB002, Inc.

Gossamer Bio Inc.

Kansas City, United States of America

Timeline & Enrollment

Phase 3

Sep 30, 2023

Oct 01, 2025

350 participants

Primary Outcome

Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (ฮ”6MWD) 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 hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Stenosis of pulmonary artery
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT05934526

Non-Device Trial