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Clinical Trial Summary

This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.


Clinical Trial Description

GPP patients who are experiencing an acute flare will be screened. Before randomization, the investigator must ensure that the subjects meet all inclusion criteria and do not meet any exclusion criteria. Subjects will be given a single intravenous infusion of HB0034 or placebo (2:1) on D1 and be hospitalized for at least 8 days after administration of the study drug (including Day 1 for administration). Thereafter, the decision of the patient's discharge will be left at the discretion of the investigator and based on the evolution of the GPP flare and the patient's health status. Subjects will be followed up to W12-W20. ;


Study Design


Related Conditions & MeSH terms

  • Generalized Pustular Psoriasis (GPP)
  • Psoriasis

NCT number NCT06231381
Study type Interventional
Source Shanghai Huaota Biopharmaceutical Co., Ltd.
Contact
Status Recruiting
Phase Phase 2
Start date February 29, 2024
Completion date November 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT02533375 - Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP) Phase 3