To Determine the Dose-dependent Efficacy and Safety of EC-18 in Patients With Moderate or Severe Atopic Dermatitis
NCT Number: NCT06487000
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Atopic Dermatitis
Interventions: DRUG: EC-18|DRUG: Placebo EC-18
Sponsor: Enzychem Lifesciences Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-05
Completion Date: 2026-12

Summary:
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

Primary Outcome Measures: Change in EASI score at 16 weeks compared to baseline, Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities)

Score range: \[0=none \~ 72=very severe\], Baseline, week 16
Secondary Outcome Measures: Change in EASI score at 4, 8, and 12 weeks compared to baseline., Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities)

Score range: \[0=none \~ 72=very severe\], Baseline, week 4, 8, 12|Percentage change in EASI score at 4, 8, 12, and 16 weeks compared to baseline, Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities)

Score range: \[0=none \~ 72=very severe\], Baseline, week 4, 8, 12, 16|Proportion of subjects achieving EASI-50, EASI-75, and EASI-90 at 4, 8, 12, and 16 weeks compared to baseline., Eczema Area Severity Index (EASI) score: Sum of the 4 region scores (Head/neck, Trunk , Upper extremities, Lower extremities)

Score range: \[0=none \~ 72=very severe\], Baseline, week 4, 8, 12, 16|Change in IGA score at 4, 8, 12, and 16 weeks compared to baseline., Investigator's Global Assessment(IGA) score: \[0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe\], Baseline, week 4, 8, 12, 16|Proportion of subjects with an IGA score of 0 or 1 and at least a 2-point reduction in IGA score at 4, 8, 12, and 16 weeks compared to baseline., Investigator's Global Assessment(IGA) score: \[0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe\], Baseline, week 4, 8, 12, 16|Change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline. Change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline. Change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline., Pruritus Numerical Rating Scale(NRS): The scale of perceived itchiness from \[0=none to 10=very severe\], Baseline, week 4, 8, 12, 16|Percentage change in pruritus NRS score at 4, 8, 12, and 16 weeks compared to baseline., Pruritus Numerical Rating Scale(NRS): The scale of perceived itchiness from \[0=none to 10=very severe\], Baseline, week 4, 8, 12, 16|Proportion of subjects with a pruritus NRS score reduction of 4 points or more at 4, 8, 12, and 16 weeks compared to baseline., Pruritus Numerical Rating Scale(NRS): The scale of perceived itchiness from \[0=none to 10=very severe\], Baseline, week 4, 8, 12, 16|Change in sleep disturbance NRS score at 4, 8, 12, and 16 weeks compared to baseline., Sleep Disturbance Numerical Rating Scale(NRS): The scale of perceived sleep disturbance from \[0=none to 10=very severe\], Baseline, week 4, 8, 12, 16|Frequency and duration of application of the rescue medication (tacrolimus ointment)., week 4 ~ week 16
Other Outcome Measures: (Exploratory) Change in DLQI score at 4, 8, 12, and 16 weeks compared to baseline., Dermatology Life Quality Index (DLQI) score \[0-1\] = No effect on patient's life \[2-5\] = Minimal effect on patient's life \[6-10\] = Moderate effect on patient's life \[11-20\] = Very large effect \[21 - 30\] = Extremely large effect, Baseline, week 4, 8, 12, 16|(Exploratory) Changes in inflammatory biomarker (cytokine) levels at 4, 8, 12, and 16 weeks compared to baseline., \[IL-4, IL-13, IL-6, IFN- γ, IL-17A, IgE\], Baseline, weeks 4, 8, 12, 16