New shot could tame tough eczema Flare-Ups
NCT ID NCT07377838
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests an injection called ADSTEM for adults with moderate-to-severe atopic dermatitis (eczema) that hasn't responded well to standard treatments. About 286 people aged 19 to 70 will receive either the study drug or a placebo. The main goal is to see if the injection can clear or nearly clear the skin rash.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 286 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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 70 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: 1. Adults aged 19 to 70 years at the time of informed consent. 2. Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria at screening. 3. History of atopic dermatitis for at least 24 weeks prior to screening. 4. Moderate-to-severe atopic dermatitis at screening, defined as: * EASI score ≥16 * SCORAD score ≥25 * Body Surface Area (BSA) involvement ≥10% * vIGA score ≥3 5. Inadequate response to prior standard topical and/or systemic treatments for atopic dermatitis, or inability to receive such treatments due to safety concerns. 6. Voluntary written informed consent provided. Exclusion Criteria: 1. Presence of clinically significant comorbidities at screening, including: * Active infection requiring antimicrobial treatment within 2 weeks prior to baseline, or superficial skin infection within 1 week prior to baseline; * Skin diseases that require ongoing treatment or may interfere with safety or efficacy assessments; * Uncontrolled asthma requiring oral corticosteroids; * Positive test results for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis; * Other uncontrolled or clinically significant medical conditions that may affect study participation or assessments; * Clinically significant abnormal laboratory results at screening (e.g., AST or ALT \> 3 × ULN, serum creatinine \> 2 × ULN). 2. History of prohibited treatments prior to baseline, including: * Use of JAK inhibitors within 4 weeks; * Use of biologic therapies for atopic dermatitis within 12 weeks; * Use of systemic immunosuppressants, immunomodulators, or systemic corticosteroids within 4 weeks; * Use of topical corticosteroids, topical PDE-4 inhibitors, or topical calcineurin inhibitors within 2 weeks; * Participation in another clinical trial with an investigational drug or device within 4 weeks prior to screening; * Prior treatment with cell therapy or gene therapy. 3. History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer without recurrence. 4. History of tanning within 4 weeks prior to baseline. 5. Pregnant or breastfeeding women, or women planning pregnancy during the study period. 6. Women of childbearing potential who are unwilling to use adequate contraception from the time of informed consent through the end of the study. 7. Known or suspected hypersensitivity to the investigational product or any of its components. 8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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