Determine the Dose-dependent Efficacy and Safety of EC-18 in Patients With Moderate to Severe Atopic Dermatitis

Sponsor
Enzychem Lifesciences Corporation
Study ID
NCT06487000
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • EC-18 — DRUG
    oral administration, QD
  • Placebo EC-18 — DRUG
    oral administration, QD

Study Details

To evaluate the efficacy and safety of oral administration of dose-dependent EC-18 for 16 weeks in patients with moderate to severe atopic dermatitis

Key Dates

First listed
Jul 5, 2024
Start date
May 31, 2027
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EC-18 1000mg
    \[EC-18 2 capsules / Placebo 2 capsules\]
  • Experimental: EC-18 2000mg
    \[EC-18 4 capsules\]
  • Placebo Comparator: Placebo
    \[Placebo 4 capsules\]

Primary Outcome Measure

Change in EASI score at 16 weeks compared to baseline [ Time Frame: Baseline, week 16 ]

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