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 States86 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 range18 Years – 75 Years
SexALL
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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.
✓. 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.
✕
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.