A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
Part of paid clinical trials in Encinitas, California.
- Sponsor
- Enveda Therapeutics
- Study ID
- NCT07643766
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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 — OTHERMatching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
Study Details
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.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ENV-294 Treatment Arm (Dose 1)
- Experimental: ENV-294 Treatment Arm (Dose 2)
- Experimental: ENV-294 Treatment Arm (Dose 3)
- Placebo Comparator: Placebo Arm
Primary Outcome Measure
Percent change in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to Week 12 ]
Central Contacts
- Clinical Operations
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Enveda Investigative Site | Encinitas | California | 92024 | - |
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