NCT07298395

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Enveda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	ENV-294	ENV-294 is an orally administered investigational drug supplied as capsules. Each participant will receive ENV-294 at a total dose of 800 milligrams (mg) once daily by mouth for 12 weeks. Capsules should be taken with water, approximately the same time each day, with or without food, as directed by the study physician.
DRUG	Placebo	Matching oral capsule that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-23
• Last updated: 2026-04-03

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study