Can a daily pill calm severe eczema from the inside?

NCT ID NCT06487000

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This phase 2 trial tests whether an oral drug called EC-18 can reduce the severity of moderate to severe atopic dermatitis, a chronic inflammatory skin condition. About 150 adults aged 19 to under 80 will take either EC-18 or a placebo once daily for 16 weeks. Researchers will measure changes in the Eczema Area and Severity Index (EASI) score, which rates redness, thickness, and scaling across body regions. The goal is to see if EC-18 offers a new systemic treatment option for people who do not get enough relief from topical therapies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EC-18, an oral drug taken once daily as a soft capsule
What this could lead to
If it works, EC-18 could offer a new daily pill option for people with moderate to severe atopic dermatitis who need more than topical creams.
What could go wrong
This is a mid-stage trial with 150 participants, so results may not hold up in larger studies. The drug may not improve symptoms enough, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: * 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) * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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