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

NCT06477536 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Phase

Phase 2/3

Started

2024-09-02

Last updated

2025-02-14

Condition(s) studied

Generalized Pustular Psoriasis

Investigational drug(s) / intervention(s)

HB0034

HB0034: 300mg, i.v. Q4W

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

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

Primary outcome measure(s)

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).

Trial sites (3)

Facility	City	Region	Status
Peking University People's Hospital (PKUPH)	Beijing	China	Recruiting
Peking University People's Hospital	Beijing	China	Recruiting
The Second affiliated Hospital zhejiang University School of Medicine	Hangzhou	China	Recruiting

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Other trials for the same condition

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares Active, not recruiting

A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP) Active, not recruiting

Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06477536 on ClinicalTrials.gov ↗ ← All trials in China