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 — DRUG
    ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
  • Placebo — OTHER
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Enveda Investigative SiteEncinitasCalifornia92024-

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