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

NCT06365879 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2026-05-08

No results posted yet for this study

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

Conditions

Interventions

DRUG

CMAB007

300mg, SC, Q4W

DRUG

Xolair

300mg, SC, Q4W

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jinhua Xu, PhD · Huashan Hospital

  • Hui Tang, PhD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365879 on ClinicalTrials.gov