drugset
drugset / Trial / NCT06365879

To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria

NCT06365879 ↗

Phase 3 Active not recruiting 392 enrolled Taizhou Mabtech Pharmaceutical Co.,Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria

Timeline

Start
2024-06-18
Primary completion
2026-01-29
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CMAB007 Monoclonal antibody 300 mg Subcutaneous
Comparator Omalizumab Monoclonal antibody 300 mg Subcutaneous

Indications

chronic idiopathic urticaria