Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HB0034.
- Who it may be relevant to
- Registry conditions: Generalized Pustular Psoriasis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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
Interventions
- Drug HB0034
300mg, i.v. Q4W
Primary outcome measures
- Safety endpoints include the proportion of subjects with TEAEs [Time frame: 0-24 weeks]
Secondary outcome measures (1)
- The recurrence of GPP flare during the study [Time frame: 0-24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Peking University People's Hospital (PKUPH) — Beijing
- Peking University People's Hospital — Beijing
- The Second affiliated Hospital zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06477536 · HB0034-05