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Not yet recruitingNCT07479615ADaggioUpdated Mar 18, 2026

A Study to Evaluate the Efficacy and Safety of MG-K10 in Participants Who Have Atopic Dermatitis

A Phase 3 interventional study of MG-K10 Humanized Monoclonal Antibody Injection in Atopic Dermatitis and Atopic Eczema, sponsored by Shanghai Mabgeek Biotech.Co.Ltd. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Shanghai Mabgeek Biotech.Co.Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
498
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

Rationale (What is the reason for this study?) Atopic dermatitis (AD) is a condition that makes the skin dry and itchy and is the most common skin condition that causes redness and irritation.

The exact cause of AD is unclear but genetic and environmental factors are believed to play a role. Common treatment options for participants with AD include basic skin care, medicine that is applied to the skin, and medicine that works in more than one part of the body. Typically, these treatment options work for participants with AD but some have skin lesions (skin sores or damaged skin) over large areas of the body and do not see an improvement in their AD symptoms. MG-K10 has been shown to be effective in treating participants with moderate-to-severeatopic dermatitis in Phase 2 studies (Chaoying Gu et al.2025) and has already completed a Phase 3 clinical study for adults in China. This study aims to evaluate the efficacy and safety of MG-K10 in the adolenscents and adults with moderate-to-severeatopic dermatitis in global population.

Objectives (goals of the study) and Endpoints (how goals are measured) Check how MG-K10 treatment affects atopic dermatitis Study doctors will look at the safety of MG-K10 and if any side effects are reported by participants when they take it.

Check how the body processes MG-K10 Check how MG-K10 affects the biomarkers of effect Check how the body's immune system (the body's defense system) reacts to MG-K10

02

Conditions studied

  • Atopic Dermatitis
  • Atopic Eczema

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03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 498 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Shanghai Mabgeek Biotech.Co.Ltd is the lead sponsor of 16 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from the time of signing the 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

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 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 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 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
    • Use of topical treatments for AD
    • Receipt of allergen-specific immunotherapy
    • Vaccination with live or attenuated
    • 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 (ECG) at screening
  16. Active hepatitis at screening, or positive for surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with hepatitis B virus DNA (HBV-DNA) positive, or positive for virus (HCV) antibodies with HCV RNA positive.
  17. History of (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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Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
498 participants (estimated)

Study arms

  • Experimental
    MG-K10 Humanized Monoclonal Antibody Injection

    After W16 patients will be re-randomize to: 1. MG-K10 Humanized Monoclonal Antibody Injection for responder Q4W 2. MG-K10 Humanized Monoclonal Antibody Injection for responder Q8W 3. Placebo Injection for responder Q4W 4. MG-K10 Humanized Monoclonal Antibody Injection for non-responder Q4W

    Biological: MG-K10 Humanized Monoclonal Antibody Injection

  • Placebo comparator
    Placebo group:

    After W16 patients will be re-randomize to: MG-K10 Humanized Monoclonal Antibody Injection Q4W

    Biological: MG-K10 Humanized Monoclonal Antibody Injection

Interventions

  • BiologicalMG-K10 Humanized Monoclonal Antibody Injection

    MG-K10 Humanized Monoclonal Antibody Injection

06

What researchers measure

Primary outcomes

  1. To evaluate the efficacy of MG K10 monotherapy compared to placebo in adults and adolescents with moderate to severe atopic dermatitis (AD).

    Proportion of participants with EASI 75

    Time frame: From baseline (D1) to 60 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07479615
Lead sponsor
Shanghai Mabgeek Biotech.Co.Ltd
Responsible party
Sponsor
First posted
Mar 18, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Mar 18, 2026

Study contacts

Yunfei Xia
Contact
yunfei.xia@mabgeek.com
+86 021-51371305

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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