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NCT Number: NCT06477536

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

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).

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Key information

Conditions

Generalized Pustular Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Peking University People's Hospital, Beijing, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HB0034

Drug

300mg, i.v. Q4W

Other names: Anti-IL-36R antibody,Recombinant Humanized anti-IL-36R Monoclonal antibody

Primary outcomes

  1. Safety endpoints include the proportion of subjects with TEAEs

    Time frame: 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 outcomes

  1. The recurrence of GPP flare during the study

    Time frame: 0-24 weeks

    The Proportion of patients who have at least once GPP flare during the study

Study contacts

Contact information is provided by the study sponsor or research team.

Guodong Zhou

CONTACT

[email protected]

+86 13636638684

Qiaoxia Qian, Master

CONTACT

[email protected]

+86 18555690860

Sponsors and collaborators

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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