Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
ConditionAtopic Dermatitis (AD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEnveda Therapeutics
About this trial
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
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 * Return to the clinic for the final study visit at approximately week 16
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
A vIGA score of 3 (moderate) or 4 (severe)
EASI score of ≥16
BSA ≥10%
Disqualifiers
Current or recurrent medical conditions that could affect the study drug or study assessments
Any illness that could impact participant safety or active infections
Ongoing skin condition or large tattoos that would interfere with clinical assessment
Clinically significant skin infection requiring treatment
Trial design
Design model
Parallel
Treatments tested in this trial
ENV-294
DrugENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Placebo
DrugMatching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: ENV-294 Treatment ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
The effectiveness of ENV-294 compared with placebo will be assessed by the percent change in Eczema Area and Severity Index (EASI) score from the start of the study (Baseline) to Week 12 (Day 85). The EASI score measures the extent and severity of atopic dermatitis, with higher scores indicating more severe disease.
Time frame
Baseline to Week 12Secondary outcomes
1
Incidence and Severity of Adverse Events
Number and seriousness of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
Time frame
Baseline to Week 122
EASI-75 Response
Percentage of participants with at least 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score.
Time frame
Baseline to Week 123
vIGA Response
Proportion of participants who achieve a ≥2-point reduction from Baseline in validated Global Investigator Assessment (vIGA) score and a score of 0 or 1.
Time frame
Baseline to Week 124
Patient-Reported Outcomes
Change and percent change in Peak Pruritus Numerical Rating Scale (PP-NRS).
Time frame
Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov