Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) (NCT05934526) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
United States390 participantsStarted 2023-12-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult subjects aged 18 to 75 years.
✓. Body mass index (BMI) ≥ 15 kg/m\^2 and ≤ 40 kg/m\^2.
✓. Diagnosis of PAH classified by one of the following:
✓. Idiopathic PAH (IPAH) or heritable PAH (HPAH).
✓. PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.
✓. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
✓. 6MWDs ≥ 150 meters and ≤ 475 meters during Screening prior to randomization.
✓. WHO FC II or III.
Exclusion criteria
✕. Evidence of chronic thromboembolic disease or acute pulmonary embolism.
✕. Uncontrolled systemic hypertension as evidenced by systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg.
✕. Systolic blood pressure \< 90 mm Hg during Screening.
✕. WHO Pulmonary Hypertension Group 2 - 5.
✕. Human immunodeficiency virus (HIV)-associated PAH, schistosomiasis associated PAH, PAH associated with portal hypertension, or pulmonary veno-occlusive disease (PVOD).
What they're measuring
1
Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24