NCT04944602

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

A Multicenter Randomized, Double-blind, Parallel, Positive-controlled Phase III Clinical Trial to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of approximately 340 patients with H1 antihistamines (H1AH) refractory CSU will be randomized into two treatments arms (SYN008 300 mg s.c., and omalizumab 300 mg s.c.) at a 1:1 ratio. Both SYN008 and omalizumab will be injected every 4 weeks as an add-on therapy on top of H1AH treatment. The study will consist of three distinct epochs over 27 weeks, as follows: * Screening epoch: Day -21 to Day -1 * Randomized-treatment epoch: Day 1 to Week 12 * Post-treatment follow-up epoch: Week 1

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	SYN008	injection of 300 mg
BIOLOGICAL	Omalizumab for injection	injection of 300 mg

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2021-06-29
• Last updated: 2021-06-29