Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-26 @ 1:38 PM
Study NCT ID:
NCT07298395
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Enveda Therapeutics
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV 294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2025-12
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 learn about the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis.
The main questions it will answer are:
* Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294
* What medical problems do participants have when taking ENV-294 Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study.
Participants will:
* Take drug ENV-294 or a placebo once every day for 12 weeks
* Visit the clinic every 2 to 4 weeks for checkups and tests
* Keep a diary of their symptoms and when they took their study drug ENV-294
* Return to the clinic for the final study visit at approximately week 16
The main questions it will answer are:
* Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294
* What medical problems do participants have when taking ENV-294 Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study.
Participants will:
* Take drug ENV-294 or a placebo once every day for 12 weeks
* Visit the clinic every 2 to 4 weeks for checkups and tests
* Keep a diary of their symptoms and when they took their study drug ENV-294
* Return to the clinic for the final study visit at approximately week 16
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: