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

Phase 2

Recruiting

• Conditions: Generalized Pustular Psoriasis
• Interventions: Drug: HB0034

• Registration Number: NCT06477536
• Lead Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

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 Timeline

• Study First Submitted: 2024-06-22
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-06-27
• Status Verified: 2024-09
• Study Start: 2024-09-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HB0034	HB0034	single-arm and all the patients would receive HB0034 300mg i.v. every other four weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Peking University People's Hospital (PKUPH); 🇨🇳 Beijing, China

The Second affiliated Hospital zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Peking University People's Hospital; 🇨🇳 Beijing, China