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New shot could soothe tough eczema for teens and adults

NCT ID NCT07479615

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests an injectable drug called MG-K10 for people aged 12 and older with moderate-to-severe atopic dermatitis (eczema) that hasn't improved with creams. About 498 participants will receive either MG-K10 or a placebo to see if it safely reduces skin redness, itching, and sores. The goal is to find a new option for those who need more than topical treatments.

What this could mean

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

Active substance
MG-K10 (a humanized monoclonal antibody injection)
What this could lead to
If successful, this could provide a new treatment option for people with moderate-to-severe atopic dermatitis who don't respond well to current therapies.
What could go wrong
This is an early-stage global study; results may not confirm effectiveness or safety. Side effects are possible, and the treatment may not work for everyone.

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 498 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jan 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

12 years and older

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. Age: ≥12 years, both males and females. 2. Diagnosed with AD (according to the 2014 American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit, and meeting the following conditions: 3. Within 6 months prior to the screening visit, the patient has shown an insufficient response to topical medication or is medically unsuitable for topical treatment (e.g., significant side effects or safety risks). 4. Participants should start a stable dose of moisturizer from the signing of ICF, apply a moisturizer twice daily for at least 7 consecutive days prior to randomization and continue using it throughout the study period. 5. Women of childbearing age have a negative blood pregnancy test result during the screening period. 6. Participants and their partners agree to use effective contraception from the time of signing the Informed Consent Form (ICF) until 6 months after the end of treatment ; no donation or freezing of germ cells is allowed from the time of signing the ICF until 6 months after the end of treatment. 7. The participant voluntarily signs the ICF and can comply with all required visits and study-related procedures outlined in the protocol. 8. For participants ≥ 12 and \< 18 years of age at Screening Visit: Parent or legal guardian, as required, has voluntarily signed and dated an informed consent form, approved by an IEC, after the nature of the stud has been explained and the participant's parent or legal guardian has had the opportunity to ask questions. Exclusion Criteria: 1. Body weight \< 30 kilograms (kg). 2. The participant currently has a diagnosis of another active skin disease that may affect AD evaluation (e.g., psoriasis or lupus erythematosus). 3. Known allergies to any component of the investigational drug. 4. The participant cannot tolerate venipuncture or have a history of needle or blood phobia. 5. The participant has comorbidities that may require systemic steroid therapy, other intervention measures, or require active and frequent monitoring. 6. Those with significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematologic, neurologic, and psychiatric disorders that are unstable or not well controlled and are considered clinically significant by the investigator. 7. Participants with ocular diseases deemed unsuitable for study entry by the investigator, such as a history of atopic keratoconjunctivitis involving the cornea. 8. Participants are planning to undergo major surgery during the study period, including inpatient and outpatient surgeries. 9. Patients with malignant tumors within 5 years 10. Participants with any of the following conditions within the related timeline: * Use of biologics * Use of targeted inhibitors (e.g., JAK inhibitors), systemic corticosteroids, cyclosporine, or other immunosuppressants * Use of topical treatments for AD * Receipt of allergen-specific immunotherapy * Vaccination with live or attenuated live vaccines * Participation in another clinical drug study * Previous use of interleukin-4 receptor alpha (IL-4Rα) or interleukin-13 (IL-13) monoclonal antibody drugs 11. Received systemic (oral or intravenous) antibacterial, antiviral, or antifungal treatment within 4 weeks prior to randomization. 12. Evidence of active tuberculosis, or previous evidence of active tuberculosis without documented adequate treatment 13. Diagnosis of active parasitic infection; suspected parasitic infection or high risk of infection unless clinical and (if necessary) laboratory evaluations have ruled out active infection prior to randomization. 14. Laboratory results at screening showing any of the abnormalities 15. Abnormal 12-lead electrocardiogram (ECG) at screening 16. Active hepatitis at screening, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with hepatitis B virus DNA (HBV-DNA) positive, or positive for hepatitis C virus (HCV) antibodies with HCV RNA positive. 17. History of human immunodeficiency virus (HIV) infection, or positive for HIV antibodies at screening 18. Positive for Treponema pallidum antibodies (TP-Ab) at screening, except if rapid plasma reagin (RPR) or Toluidine Red Unheated Serum Test (TRUST) results are negative 19. History of illicit drug use, drug abuse, or excessive alcohol consumption 20. Women who are breastfeeding, pregnant, or planning to become pregnant or breastfeed during the study period. 21. Any other conditions that the investigator considers inappropriate for study participation. \-

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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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.