Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04944602
Status:
UNKNOWN
Last Update Posted:
2021-06-29
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria
Sponsor:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
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, 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
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
Study Oversight
Has Oversight DMC:
False
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?: