New shot could soothe tough eczema for teens and adults
NCT ID NCT07479615
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 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. 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. \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atopic dermatitis are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Skin scans may predict who responds to dupilumab for eczema
- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
- Scientists probe whether lebrikizumab rewires diseased skin at the molecular level
- Can a Lab-Made antibody calm severe eczema?
- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?