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

Last updated: February 12, 2025
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Psoriasis And Psoriatic Disorders

Rosacea

Warts

Treatment

HB0034

Clinical Study ID

NCT06477536
HB0034-05
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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 theInvestigator's judgment

  • Men and women of reproductive age who have no parenting plans and are willing to usereliable contraception during the study period and for 6 months after the last doseof the study drug;

  • Patients who fully understand and voluntarily sign an ICF, and are willing and ableto follow clinical study and subsequent visit schedules

Exclusion

Exclusion Criteria:

  • Patients who are experiencing GPP flare

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: HB0034
Phase: 2/3
Study Start date:
September 02, 2024
Estimated Completion Date:
June 30, 2026

Study Description

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

Connect with a study center

  • Peking University People's Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University People's Hospital (PKUPH)

    Beijing,
    China

    Active - Recruiting

  • The Second affiliated Hospital zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

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