A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 33
- Locations
- 3
- Primary Endpoint
- Safety endpoints include the proportion of subjects with TEAEs
Overview
Brief Summary
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).
Detailed Description
This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients who are experiencing GPP flare
Arms & Interventions
HB0034
single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks
Intervention: HB0034 (Drug)
Outcomes
Primary Outcomes
Safety endpoints include the proportion of subjects with TEAEs
Time Frame: 0-24 weeks
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(0-24 weeks)