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

NCT06487000 | Not Yet Recruiting Phase 2

• 1 other identifier: EC-18-205
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in EASI score at 4, 8, and 12 weeks compared to baseline.

  Baseline, week 4, 8, 12

• Percentage change in EASI score at 4, 8, 12, and 16 weeks compared to baseline

  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.

  Baseline, week 4, 8, 12, 16

• Change in IGA score at 4, 8, 12, and 16 weeks compared to baseline.

  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.

  Baseline, week 4, 8, 12, 16

Other Outcomes (2)

• (Exploratory) Change in DLQI score at 4, 8, 12, and 16 weeks compared to baseline.

  Baseline, week 4, 8, 12, 16

• (Exploratory) Changes in inflammatory biomarker (cytokine) levels at 4, 8, 12, and 16 weeks compared to baseline.

  Baseline, weeks 4, 8, 12, 16

Study Arms (3)

EC-18 1000mg

EXPERIMENTAL

\[EC-18 2 capsules / Placebo 2 capsules\]

Drug: EC-18; Drug: Placebo EC-18

EC-18 2000mg

EXPERIMENTAL

\[EC-18 4 capsules\]

Drug: EC-18

Placebo

PLACEBO COMPARATOR

\[Placebo 4 capsules\]

Drug: Placebo EC-18

Interventions

EC-18 DRUG

oral administration, QD

Also known as: EC-18 soft capsules

EC-18 1000mg; EC-18 2000mg

Placebo EC-18 DRUG

oral administration, QD

EC-18 1000mg; Placebo

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of screening:
• aged 19 to under 80 at the time of written consent.
• Patients diagnosed with atopic dermatitis according to the Hanifin and Rajka criteria (≥3 major symptoms out of 4 and ≥3 minor symptoms out of 23) for at least 12 months prior to screening
• Patients requiring systemic therapy for disease control due to either a documented inadequate response to topical drug treatment for at least 4 weeks (within 6 months prior to screening visit), or where topical therapy is medically not recommended (due to significant side effects or safety concerns)
• Patients with Moderate to Severe Atopic dermatitis
• BSA ≥ 10%
• EASI score ≥16
• IGA score ≥3
• Pruritus NRS score ≥3
• Patients who have been fully informed about this clinical trial, have voluntarily decided to participate, and have provided written consent to faithfully comply with the trial requirements.
• At the time of baseline visit
• Signed informed consent
• Patients who have used emollients continuously for the 7 days prior to baseline visit

You may not qualify if:

• Patients with serious skin conditions other than atopic dermatitis (e.g. psoriasis, discoid lupus erythematosus, or erythema multiforme that, as judged by the investigator, would adversely affect the evaluation of atopic dermatitis)
• Patients with a history of chronic immunosuppression
• Patients with ongoing malignant tumors at screening or diagnosed within the last 5 years
• Patients who have undergone bone marrow or organ transplantation
• Patients with hypertension (e.g. systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg)
• Patients with ulcerative or erosive lesions
• Patients with Netherton's Syndrome
• Patients with clinically significant severe infections (e.g. infections requiring prolonged antibiotic or immunotherapy treatment) or severe trauma as judged by the investigator
• Patients with positive serum test results at screening (HBs Ag, HCV Ab, HIV Ab). However, patients with a positive HCV Ab result may be eligible if they have achieved HCV RNA negativity after treatment
• Patients at screening (Visit 1) with laboratory test results falling under the following criteria:
• HbA1c ≥ 7%(Despite medication treatment)
• ALT and AST ≥ 5 times the upper limit of normal (ULN)
• eGFR (CKD-EPI\_ \< 30 ml/ min/1.73m²
• Serum potassium \> 5.5 mEq/L
• LDL-C \>190mg/dL or TC \> 500mg/dl (Despite medication treatment)

Sponsors & Collaborators

• Enzychem Lifesciences Corporation: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11