A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ENV-294, Placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Overview
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. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.
Interventions
- Drug ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks. - Other Placebo
Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Primary outcome measures
- Percent change in Eczema Area and Severity Index (EASI) score [Time frame: Baseline to Week 12]
Secondary outcome measures (6)
- Incidence of Treatment Emergent Adverse Events [Time frame: Baseline to Week 12 and Week 16]
- EASI-75 Response [Time frame: Baseline to Week 12]
- vIGA Response [Time frame: Baseline to Week 12]
- Percent change in Scoring Atopic Dermatitis (SCORAD) [Time frame: Baseline to Week 12]
- Patient-Reported Outcomes [Time frame: Baseline to Week 12]
- Patient-Reported Outcomes [Time frame: Baseline to Week 12]
Eligibility criteria
Inclusion 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 before Screening.
- 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.
Exclusion criteria
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 study results.
- 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 the investigator.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Enveda Investigative Site — Encinitas
- Enveda Investigative Site — Los Angeles
- Enveda Investigative Site — Northridge
- Enveda Investigative Site — Boca Raton
- Enveda Investigative Site — Indianapolis
- Enveda Investigative Site — Plainfield
- Enveda Investigative Site — Dallas
- Enveda Investigative Site — San Antonio
- … and 1 more center
Identifiers
NCT: NCT07643766 · ENV-294-202