This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).
This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
300mg, i.v. Q4W
Peking University People's Hospital (PKUPH)
Beijing, China
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGThe Second affiliated Hospital zhejiang University School of Medicine
Hangzhou, China
RECRUITINGSafety 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: 0-24 weeks
The recurrence of GPP flare during the study
The Proportion of patients who have at least once GPP flare during the study
Time frame: 0-24 weeks
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