Atopic Dermatitis
Conditions
Brief summary
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
DRUGENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
OTHERPlacebo
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.
Sponsors
Enveda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to participate in this study all participants must: 1. Be at least 18 years of age at the time of signing the ICF. 2. Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening. 3. 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. 4. Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria: 1. A vIGA score of 3 (moderate) or 4 (severe) 2. EASI score of ≥16 3. Body surface area involvement of ≥10% 5. Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average. 6. 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. 7. Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.
Exclusion criteria
Participants are excluded if they: 1. 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. 2. Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator. 3. 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. 4. 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. 5. 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. 6. Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Eczema Area and Severity Index (EASI) score | Baseline to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | Baseline to Week 12 and Week 16 | — |
| EASI-75 Response | Baseline to Week 12 | Proportion of participants with at least 75% reduction from Baseline in EASI score |
| vIGA Response | Baseline to Week 12 | 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. |
| Percent change in Scoring Atopic Dermatitis (SCORAD) | Baseline to Week 12 | — |
| Patient-Reported Outcomes | Baseline to Week 12 | Change in Patient Oriented Eczema Measure (POEM) |
Countries
United States
Contacts
CONTACTClinical Operations
STUDY_DIRECTORGurpreet Ahluwalia, PhD
Enveda Therapeutics, Inc.
Outcome results
None listed