Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365879
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-07
Brief Title:
To Compare Efficacy and Safety of CMAB007 and Xolair in Patients With Chronic Spontaneous Urticaria
Sponsor:
Taizhou Mabtech Pharmaceutical CoLtd
Organization:
Taizhou Mabtech Pharmaceutical CoLtd
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Positive Parallel Controlled Phase III Clinical Trial to Compare Omalizumab αCMAB007 and Xolair in Patients With Chronic Spontaneous Urticaria
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 αCMAB007 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None