Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT05108766
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2021-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
Sponsor:
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase Ⅲ, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
Status:
COMPLETED
Status Verified Date:
2023-04
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 is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis.
The trial was divided into two parts: the base study (Week 0- Week 12) and the extension study (Week 13- Week 54).
The trial was divided into two parts: the base study (Week 0- Week 12) and the extension study (Week 13- Week 54).
Detailed Description:
Base Study： 220 subjects were randomized in a 1: 1 ratio into the trial, and the treatment group received 100 mg subcutaneous Tildrakizumab at Week 0 and Week 4, 100 mg subcutaneous placebo at Week 12, while the placebo group received 100 mg subcutaneous placebo at Week 0 and Week 4, and 100 mg subcutaneous Tildrakizumab at Week 12, and subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity as specified in this protocol. At the end of the base study, procedures such as data cleaning, locking and unblinding of base study data were performed.
Extension Study： Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52, and will be evaluated for efficacy, safety, tolerability, and immunogenicity by the investigator according to the regulations of this study.
At the end of the extension study, all data from the extension study will be entered into the database, after the data is reviewed, cleaned, and locked, the entire trial will be analyzed.
Extension Study： Subjects entered the extension study after completion of the base study and will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52, and will be evaluated for efficacy, safety, tolerability, and immunogenicity by the investigator according to the regulations of this study.
At the end of the extension study, all data from the extension study will be entered into the database, after the data is reviewed, cleaned, and locked, the entire trial will be analyzed.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: