The phase III STARScape trial evaluated the efficacy and safety of zinpentraxin alfa in patients with idiopathic pulmonary fibrosis (IPF). The 52-week, double-blind, placebo-controlled study was conducted at 275 sites in 29 countries. Patients were randomized 1:1 to receive either zinpentraxin alfa 10 mg/kg every 4 weeks or placebo. The primary endpoint was the change in forced vital capacity (FVC) from baseline to Week 52. Secondary endpoints included changes in percent predicted FVC and 6-minute walk distance. The trial was terminated early due to a prespecified futility analysis, showing no significant difference between zinpentraxin alfa and placebo in FVC change (-214.89 ml vs. -235.72 ml, P = 0.5420). No significant differences were observed in secondary endpoints, and adverse events were generally comparable between groups. Post hoc analysis of phase II data revealed that extreme FVC decline in two placebo-treated patients influenced the reported clinical benefit of zinpentraxin alfa. The study concluded that zinpentraxin alfa did not provide additional benefit over placebo in IPF patients and highlighted the importance of careful data analysis and handling of outliers in clinical trials.The phase III STARScape trial evaluated the efficacy and safety of zinpentraxin alfa in patients with idiopathic pulmonary fibrosis (IPF). The 52-week, double-blind, placebo-controlled study was conducted at 275 sites in 29 countries. Patients were randomized 1:1 to receive either zinpentraxin alfa 10 mg/kg every 4 weeks or placebo. The primary endpoint was the change in forced vital capacity (FVC) from baseline to Week 52. Secondary endpoints included changes in percent predicted FVC and 6-minute walk distance. The trial was terminated early due to a prespecified futility analysis, showing no significant difference between zinpentraxin alfa and placebo in FVC change (-214.89 ml vs. -235.72 ml, P = 0.5420). No significant differences were observed in secondary endpoints, and adverse events were generally comparable between groups. Post hoc analysis of phase II data revealed that extreme FVC decline in two placebo-treated patients influenced the reported clinical benefit of zinpentraxin alfa. The study concluded that zinpentraxin alfa did not provide additional benefit over placebo in IPF patients and highlighted the importance of careful data analysis and handling of outliers in clinical trials.