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

Shanghai Huaota Biopharmaceutical

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Generalized Pustular Psoriasis

Treatments: Drug: HB0034

Study type: Interventional

Funder types: Industry

Identifiers

NCT06477536

HB0034-05

Details and patient eligibility

About

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).

Full description

This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

HB0034

Experimental group

Description:

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

Treatment:

Drug: HB0034