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.
GPP patients who are experiencing an acute flare will be screened. Before randomization, the investigator must ensure that the subjects meet all inclusion criteria and do not meet any exclusion criteria. Subjects will be given a single intravenous infusion of HB0034 or placebo (2:1) on D1 and be hospitalized for at least 8 days after administration of the study drug (including Day 1 for administration). Thereafter, the decision of the patient's discharge will be left at the discretion of the investigator and based on the evolution of the GPP flare and the patient's health status. Subjects will be followed up to W12-W20.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Peking University People's Hospital (PKUPH)
Beijing, China
RECRUITINGShanghai Huaota Biopharmaceutical Co., Ltd
Shanghai, China
RECRUITINGProportion of subjects who achieved GPPGA pustulation subscore of 0/1 (no/almost no visiable pustules) at Week 1.
Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)
Time frame: Week 1
Percent (%) improvement from baseline in GPPASI at Week 1
Generalized Pustular Psoriasis Area and Severity Index (GPPASI)
Time frame: Week 1
Safety endpoints include the proportion of subjects with TEAEs.
The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG).
Time frame: 12-20 Weeks
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