About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients participated in the preceding placebo-controlled Phase 2 study (HB0034-04)and completed at least the Week 12 visit of the HB0034-04 study
Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
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
Disqualifiers
Patients who are experiencing GPP flare
Trial design
Single group
Treatments tested in this trial
HB0034
Drug300mg, i.v. Q4W
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
The recurrence of GPP flare during the study
The Proportion of patients who have at least once GPP flare during the study
Sponsors and contacts
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