Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539639
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2020-09-01
Brief Title:
Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis
Sponsor:
Suzhou Zelgen Biopharmaceuticals CoLtd
Organization:
Suzhou Zelgen Biopharmaceuticals CoLtd
Study Overview
Official Title:
A Multi-centerRandomizedDouble-blindPlaceboParallel-controlled Phase II Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
AD
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis
Detailed Description:
The study is divided into two stages the first stage test 1-12 weeks the main test the second stage test 13-24 weeks the extended test
The main testThe trial set up 4 treatment groups including 3 dose exploration groups Jaktinib 50mg Bid 75mg Bid 100mg Bid group and 1 placebo control group
The extended testSubjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid 75mg Bid and 100mg Bid treatments at a ratio of 111 randomized in a blinded state and completed by IWRS in the background the main test group 50mg Bid 75mg Bid 100mg Bid group subjects still maintain the original dose after 12 weeks
The main testThe trial set up 4 treatment groups including 3 dose exploration groups Jaktinib 50mg Bid 75mg Bid 100mg Bid group and 1 placebo control group
The extended testSubjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid 75mg Bid and 100mg Bid treatments at a ratio of 111 randomized in a blinded state and completed by IWRS in the background the main test group 50mg Bid 75mg Bid 100mg Bid group subjects still maintain the original dose after 12 weeks
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