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RECRUITING
NCT07298395
PHASE2

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

Sponsor: Enveda Therapeutics

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-12-22

Completion Date

2026-12

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

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.

Locations (17)

Cahaba & Skin Health Center

Birmingham, Alabama, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Center for Dermatology Clinical Research

Fremont, California, United States

Dermatology Cosmetic Laser Associates of La Jolla

San Diego, California, United States

TCR Medical Corporation

San Diego, California, United States

Southern Indiana Clinical Trials

New Albany, Indiana, United States

Options Research Group

West Lafayette, Indiana, United States

Skin Sciences

Louisville, Kentucky, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

Apex Clinical Research Center

Canton, Ohio, United States

Best Skin Research

Camp Hill, Pennsylvania, United States

Arlington Research Center

Arlington, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Virginia Dermatology & Skin Cancer Center

Norfolk, Virginia, United States