Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-14
Brief Title:
A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Simcere Pharmaceutical Co Ltd
Organization:
Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 will evaluate the efficacy and safety of SIM0718 in adolescents 12- 18 years and adults 18-75 years with moderate to severe AD
Detailed Description:
This is a randomized double-blind placebo-controlled multicenter clinical study to evaluate the efficacy and safety of SIM0718 in adolescents 12- 18 years and adults 18-75 years with moderate to severe AD Subjects who meet entry criteria will be randomized to receive either SIM0718 or matching placeboThe study includes a screening period a treatment period and a follow-up period
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