Print

Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit - Have had either: (1) a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months, as determined by the study doctor, or (2) a poor response to treatments administered by mouth within the past 12 months. - Use a bland moisturizer at least daily

Exclusion Criteria

  • Current or recurrent medical conditions that could affect the study drug or study assessments, including but not limited to: cardiovascular, neurological, kidney, liver, gastrointestinal, cancer, autoimmune disease, HIV, hepatitis B, hepatitis C, or psychiatric disorders. - Any illness that could impact participant safety, clinically significant depression (as determined by the investigator), or active bacterial, fungal, or viral infections. - Have an ongoing skin condition or large tattoos that would interfere with the clinical assessment, evaluation of atopic dermatitis, or treatment response. - Have an ongoing clinically significant skin infection or receiving treatment for infection that may interfere with assessment of atopic dermatitis. - Have clinically significant abnormal clinical laboratory assessments at the first or second study visit as determined by the Investigator.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ENV-294 Treatment Arm 		ENV-294 will be administered to those participants randomized to the treatment arm.
  • 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.
Placebo Comparator
Placebo Arm 		A placebo (matching the appearance of the experimental drug) will be administered to those participants who are randomized to the placebo arm.
  • 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.

Recruiting Locations

Options Research Group
West Lafayette 4928096, Indiana 4921868 47906
Contact:
Study Coordinator
317-776-8822
k.gibbons@optionsresearchgroup.com

More Details

Status
Recruiting
Sponsor
Enveda Therapeutics

Study Contact

Jill Sr. Clinical Trial Manager
817-507-9528
jill.burrow@enveda.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.