Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921969
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2021-06-07
Brief Title:
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis TRuE-AD3
Sponsor:
Incyte Corporation
Organization:
Incyte Corporation
Study Overview
Official Title:
A Phase 3 Double-Blind Randomized Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children Ages 2 Years to 12 Years With Atopic Dermatitis TRuE-AD3
Status:
COMPLETED
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:
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis This is a randomized double-blind Vehicle Controlled study Participants will be randomized 221 to blinded treatment with ruxolitinib cream 075 15 or vehicle cream with stratification by baseline IGA score and age At Week 8 efficacy will be evaluated Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety LTS period with the same treatment regimen except those initially randomized to vehicle cream will be rerandomized 11 in a blinded manner to 1 of the 2 active treatment groups ruxolitinib cream 075 or 15
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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