A Phase II, Multicenter, Double-blind, Randomized, Placebo Parallel-controlled Trial to Evaluate the Efficacy and Safety of HB0034 in Patients with GPP Presenting with an Acute Flare of Moderate to Severe Intensity
This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
• Patients must be experiencing an acute GPP flare of moderate-to-severe intensity at baseline, defined as:
‣ A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of ≥ 3;
⁃ New appearance or worsening of existing pustules, and a GPPGA pustulation subscore of ≥ 2;
⁃ ≥ 5% Body Surface Area (BSA) covered with pustules.
• Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;
• Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules.