Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374979
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Efficacy and Safety of Ixekizumab in Patients With Refractory Guttate Psoriasis
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Efficacy and Safety of Ixekizumab in Patients With Refractory Guttate Psoriasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis The main question it aims to answer is
What percentage of participants achieved more than 90 reduction from baseline in Psoriasis Area Index PASI 90 after 12 weeks of ixekizumab treatment Participants will receive a 12-week treatment of ixekizumab with follow-up visits every 2 weeks during the treatment period Keep a diary of their symptoms and Psoriasis Area Index
What percentage of participants achieved more than 90 reduction from baseline in Psoriasis Area Index PASI 90 after 12 weeks of ixekizumab treatment Participants will receive a 12-week treatment of ixekizumab with follow-up visits every 2 weeks during the treatment period Keep a diary of their symptoms and Psoriasis Area Index
Detailed Description:
This study was a single-arm open-label single-center multi-dose trial Approximately 50 participants are scheduled to receive subcutaneous injection of ixekizumab for 12 weeks with follow-up every 2 weeks during the treatment period After the treatment period the primary endpoint was assessed at week 16 and patients who achieved PASI 90 response were followed up at week 34 and week 52 to the medical center to assess disease recurrence or progression To evaluate the efficacy of ixekizumab in the treatment of refractory guttate psoriasis
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