GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) (NCT04456998) | Clinical Trial Compass
CompletedPhase 2
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
United States, Australia, Austria86 participantsStarted 2020-11-12
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A current diagnosis of symptomatic PAH classified by one of the following:
. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).
. PAH associated with connective tissue disease (CTD-APAH).
. PAH associated with anorexigen or methamphetamine use.
. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
. 6MWD ≥ 150 meters and ≤ 550 meters at screening.
. WHO FC II or III symptomatology.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
Timeframe: Baseline, Week 24
Trial details
NCT IDNCT04456998
SponsorGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
. Treatment with standard of care PAH background therapies.
Exclusion criteria
. Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary angiogram prior to screening.
. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mm Hg or sitting diastolic blood pressure \> 100 mm Hg during screening visit after a period of rest.
. Systolic blood pressure \< 90 mm Hg during screening and baseline visits.
. WHO Pulmonary Hypertension Group 2-5.
. Human immunodeficiency virus (HIV)-associated PAH.
. History of left-sided heart disease and/or clinically significant cardiac disease.
. Untreated severe obstructive sleep apnea.
. History of atrial septostomy within 180 days prior to screening.