Can a daily pill calm severe eczema from the inside?
NCT ID NCT06487000
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 79 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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