Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria

Phase 3 Unknown 340 enrolled CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

• This study is a multicenter, randomized, double-blind, parallel-group, positive-controlled phase III study to evaluate the therapeutic equivalence of SYN008 versus omalizumab for injection (Xolair®) in the treatment of CSU patients who remain symptomatic despite antihistamine treatment.

Timeline

Start: 2021-07
Primary completion: 2023-03
Completion: 2023-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Omalizumab	Monoclonal antibody	300 mg	Subcutaneous
Subject	SYN008	Unknown	300 mg	Subcutaneous

Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria

Summary

Timeline

Drugs

Indications