Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598269
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-10-05
Brief Title:
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
Sponsor:
Aclaris Therapeutics Inc
Organization:
Aclaris Therapeutics Inc
Study Overview
Official Title:
A Phase 2a Multicenter Randomized Double-blind Vehicle-controlled Parallel-group Study to Determine the Safety Tolerability Pharmacokinetics and Efficacy of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2023-09
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 first-in-human randomized double-blind parallel-group vehicle-controlled study to evaluate the efficacy safety tolerability and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis AD
Detailed Description:
Participants underwent screening evaluations to determine eligibility up to 30 days prior to randomization Participants who meet all the entry criteria were randomized on Day 1 to active or vehicle treatment Participants applied study drug ATI-1777 topical solution 20 ww or vehicle twice daily for 4 weeks with weekly study visits and were to return 2 weeks after the last dose of study medication for a Post treatment Follow-up PTFU Visit
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