NCT06231381

Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)

A Phase II, Multicenter, Double-blind, Randomized, Placebo Parallel-controlled Trial to Evaluate the Efficacy and Safety of HB0034 in Patients with GPP Presenting with an Acute Flare of Moderate to Severe Intensity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Generalized Pustular Psoriasis (GPP)

Interventions

Type	Name	Description
DRUG	HB0034	Anti-IL-36R antibody
OTHER	Placebo	non-biologically active drug

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-02-13
• Completion: 2025-11-30
• First posted: 2024-01-30
• Last updated: 2025-03-19

Locations

2 sites across 1 country: China