NCT06250400

Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Study：Clinical Study of Efficacy and Safety of Histamine Human Immunoglobulin (ShuYangMinNing) in the Treatment of Chronic Spontaneous Urticaria (CSU)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Hangzhou Grand Biologic Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of chronic spontaneous urticaria.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	human histaglobulin	once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;
BIOLOGICAL	placebo	once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;
DRUG	Loratadine 10 Mg	orally, 10mg once a day for 4 weeks

Timeline

• Start date: 2024-03-31
• Primary completion: 2025-07-01
• Completion: 2025-12-31
• First posted: 2024-02-09
• Last updated: 2024-02-09