Trial studying safety and effects for Atopic Dermatitis
Official title A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07643766
What this study is testing
What is ENV-294?
ENV-294 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to participate in this study all participants must:
- Be at least 18 years of age at the time of signing the ICF.
- Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
- Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening...
- Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:
You likely can't join if
- Participants are excluded if they:
- Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator...
- Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
- Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical...
- Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined...
- Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of...
See the full eligibility criteria
- In order to participate in this study all participants must:
- Be at least 18 years of age at the time of signing the ICF.
- Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
- Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and/or inadequate response to a systemic therapy within 12 months...
- Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:
- A vIGA score of 3 (moderate) or 4 (severe)
- EASI score of ≥16
- Body surface area involvement of ≥10%
- Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
- Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.
- Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.
- Participants are excluded if they:
- Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of...
- Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
- Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response as determined by...
- Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator.
- Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.
- Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Encinitas, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Boca Raton, Florida, United States
- Indianapolis, Indiana, United States
- Plainfield, Indiana, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Sugar Land, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encinitas, California, United States; Los Angeles, California, United States; Northridge, California, United States; Boca Raton, Florida, United States; Indianapolis, Indiana, United States; Plainfield, Indiana, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.