Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06477536

Enrollment

Registered

2024-06-27

Start date

2024-09-02

Completion date

2026-06-30

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Pustular Psoriasis

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

Interventions

DRUGHB0034

300mg, i.v. Q4W

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety endpoints include the proportion of subjects with TEAEs	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

Measure	Time frame	Description
The recurrence of GPP flare during the study	0-24 weeks	The Proportion of patients who have at least once GPP flare during the study

Countries

China

Contacts

Primary ContactGuodong Zhou

guodong.zhou@huaota.com+86 13636638684

Backup ContactQiaoxia Qian, Master

qiaoxia.qian@huaota.com+86 18555690860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026