NCT06365879

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

A Multicenter, Randomized, Double-Blind, Positive Parallel Controlled Phase III Clinical Trial to Compare Omalizumab α(CMAB007) and Xolair® in Patients With Chronic Spontaneous Urticaria

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (estimated)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study will consist of three periods: a screening period (up to 2 weeks), a 12-week treatment period and a 8-week follow-up period. The total duration of the study is up to 22 weeks. After signing informed consent, subjects who meet the inclusion criteria and do not meet the exclusion criteria will be assigned to the CMAB007 or Xolair® in a 1:1 ratio. The subjects will treated with three doses of CMAB007 or Xolair®, subcutaneous injection every four weeks in the treatment period. After the end of the treatment period, an 8-week safety follow-up was conducted. The type and dosage of H1 antihistamines remained stable in the study.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	CMAB007	300mg, SC, Q4W
DRUG	Xolair	300mg, SC, Q4W

Timeline

• Start date: 2024-06-18
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2024-04-15
• Last updated: 2025-11-19

Locations

1 site across 1 country: China