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Atopic DermatitisPhase 2NCT06487000

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

A Phase 2 study testing EC-18 in people with Atopic Dermatitis, run by Enzychem Lifesciences Corporation.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 79 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
EC-18
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
No sites listed yet
Study dates
May 2027to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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)
  • Patients with hypersensitivity reactions to the components of the investigational durg or its formulations
  • Treatment with topical corticosteroids, local calcineurin inhibitors, topical Janus kinase inhibitors, Tars, antibiotic cream, topical or oral antihistamines within the past 7 days prior to baseline
  • Patients who have undergone sunbathing, tanning bed use, ultraviolet B (UVB) therapy, or PUVA (psoralen + ultraviolet A (UVA)) therapy for relief of atopic dermatitis symptoms within the 14 days prior to baseline
  • Treatment with systemic immunosuppressants/immunomodulators and/or systemic corticosteroids within the 28 days prior to baseline (patients who have used stable doses of inhaled corticosteroids or nasal sprays for more than 3 months are eligible to participate)
  • Patients who have received treatment with biologics other than dupilumab within 3 months prior to baseline.
  • Patients who have received treatment with dupilumab within 3 months prior to baseline
  • Patients with a history of drug or alcohol abuse within 1 year prior to screening
  • Pregnant or breastfeeding women.
  • Women who test positive for pregnancy at screening or who plan to become pregnant during the clinical trial period and up to one month after the end of the investigational drug administration, or who do not agree to use appropriate contraception*, and men.
  • Appropriate contraception: complete abstinence, hormonal contraceptives without known drug interactions [levonorgestrel intrauterine system (IUS) (Mirena), medroxyprogesterone], surgical sterilization (vasectomy, bilateral tubal ligation, etc.). Note that periodic abstinence (e.g., ovulation timing, symptothermal method, or post- ovulation) or withdrawal is not considered appropriate contraception.
  • Patients who have received any investigational drug within 6 months prior to screening (those who have not received an investigational drug or who have participated in non-interventional observational studies are eligible)
  • Other patients deemed unsuitable for participation in this clinical trial by the investigator.

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-Center Phase 2 Clinical Trial to Evaluate Efficacy and Safety of EC-18 in Moderate to Severe Atopic Dermatitis

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

Read the detailed description

This study will utilize a randomized, double blind, placebo-controlled, parallel-group, multi-Center design. The Experimental group 1 will receive 1000mg of EC-18[2 capsules of EC-18 500mg, 2 capsules of placebo]. The experimental group 2 will receive 2000mg of EC-18 [4 capsules of EC-18]. The placebo group will receive 4 capsules of placebo. The time frame of this clinical trial will consist 16 weeks.

Being tested
EC-18, Placebo EC-18
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EC-18Drug

    Also called EC-18 soft capsules

    oral administration, QD

  • Placebo EC-18Drug

    oral administration, QD

Study groups in NCT06487000
Study groupRoleWhat they receive
EC-18 1000mgExperimental[EC-18 2 capsules / Placebo 2 capsules]
Receives: Drug: EC-18; Drug: Placebo EC-18
EC-18 2000mgExperimental[EC-18 4 capsules]
Receives: Drug: EC-18
PlaceboPlacebo comparator[Placebo 4 capsules]
Receives: Drug: Placebo EC-18

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: Baseline, week 16

Secondary outcomes (10)

  1. 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]

    Measured: Baseline, week 4, 8, 12

  2. 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]

    Measured: Baseline, week 4, 8, 12, 16

  3. 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]

    Measured: Baseline, week 4, 8, 12, 16

  4. 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]

    Measured: Baseline, week 4, 8, 12, 16

  5. 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]

    Measured: Baseline, week 4, 8, 12, 16

  6. 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]

    Measured: Baseline, week 4, 8, 12, 16

  7. 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]

    Measured: Baseline, week 4, 8, 12, 16

  8. 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]

    Measured: Baseline, week 4, 8, 12, 16

  9. 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]

    Measured: Baseline, week 4, 8, 12, 16

  10. Frequency and duration of application of the rescue medication (tacrolimus ointment).

    Measured: week 4 ~ week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study startMay 2027 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06487000
Sponsor's protocol ID
EC-18-205
Status last verified
Aug 2026
First submitted
27 Jun 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EC-18 in people with Atopic Dermatitis, run by Enzychem Lifesciences Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EASI score at 16 weeks compared to baseline (time frame: Baseline, week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487000.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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