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New shot could tame tough eczema Flare-Ups

NCT ID NCT07377838

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 286 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 70 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: 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

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  1. The official record

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  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.