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.
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;
Drug-triggered acute generalized exanthematous pustulosis (AGEP);
Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO);
Other active inflammatory or autoimmune diseases requiring systemic treatment with immunosuppressants, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), inflammatory bowel disease, and uveitis.
Patients with an increased risk of infectious complications as assessed by the investigator (e.g., a recent suppurative infection, any congenital or acquired immunodeficiency, such as HIV infection, prior organ or stem cell transplantation);