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Efficacy of comekibart Injection in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with Atopic Dermatitis experience red, itchy, and inflamed skin that can be difficult to control, especially when the condition is moderate-to-severe, meaning the rash covers large areas and causes significant discomfort. The study investigates a new treatment called MG-K10, which is a laboratory‑made protein (a humanized monoclonal antibody) designed to calm the immune system, and it is given as a subcutaneous injection, an injection placed just under the skin. A matching placebo that looks the same but contains no active medicine is also used for comparison.

The purpose of the study is to find out whether MG‑K10 improves the skin condition and reduces itching better than the placebo. Participants will be randomly assigned to receive either the MG‑K10 injection or the placebo, and they will receive a series of injections over several weeks while researchers track how the skin changes and how much itching is reduced.

During the study, participants will visit the clinic regularly for safety checks and to answer simple questions about their symptoms. Doctors will look at the extent of the rash, how severe it is, and how much itching the person feels, using easy‑to‑understand rating scales, to see if the treatment provides a meaningful benefit.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Randomization

    After you agree to participate, you are assigned by a computer system to receive either the active drug or a matching placebo, and you will not know which one you receive.

  2. Step 2

    Baseline Visit

    During the first clinic visit, study staff evaluate the severity of your atopic dermatitis, record measurements of the affected skin area, and collect any required laboratory samples.

    These assessments create a reference point that will be used to compare later results.

  3. Step 3

    First Injection

    You receive a subcutaneous injection (injection under the skin) of either comekibart at a dose of 600 mg or a matching placebo that contains no active ingredient.

    The injection is administered using a pre‑filled syringe prepared by the study team.

  4. Step 4

    Regular Follow‑up Visits

    You return to the clinic at the intervals defined by the study protocol for safety checks and to receive additional injections of the same product (either comekibart or placebo).

    Each visit includes a brief physical examination and may include repeat laboratory testing as required by the study.

  5. Step 5

    Weekly Symptom Diary

    You record the intensity of itching each day using a numeric rating scale and note any side effects or other symptoms you experience.

    The diary is reviewed by study staff at each follow‑up visit to monitor your condition over time.

  6. Step 6

    Week‑16 Assessment

    After 16 weeks of treatment, you undergo a comprehensive evaluation that includes measurement of skin improvement (EASI‑75), physician’s global assessment (IGA score), and the average change in itch score.

    If you meet the predefined response criteria, the study protocol may re‑randomize you to continue receiving the same injection for an extended period.

  7. Step 7

    Continued Treatment for Responders

    If you are re‑randomized, you continue to receive the same subcutaneous injection of comekibart (or placebo) at the scheduled intervals until week 52.

    These additional doses follow the same dosage of 600 mg per injection as used at the start of the study.

  8. Step 8

    Week‑52 Final Assessment

    At week 52, you have a final set of evaluations to determine the long‑term effect of the treatment on your atopic dermatitis.

    The assessment includes the same skin‑severity measurements and itch‑score analysis performed at earlier visits.

  9. Step 9

    End of Study

    After the final assessment, you complete all study procedures and receive instructions for any post‑study care that may be needed.

Who can join the trial?

13 criteria

  • Be at least 12 years old (both males and females); if you live in the Czech Republic you must be 18 years or older.
  • Have a diagnosis of moderate‑to‑severe atopic dermatitis (a chronic, itchy skin condition) that has been present for one year or more before the screening visit.
  • Score 16 or higher on the Eczema Area and Severity Index (EASI) at both the screening and baseline visits. EASI is a tool doctors use to measure how much skin is affected and how severe the rash is.
  • Score 3 or higher on the Investigator’s Global Assessment (IGA) at both the screening and baseline visits. IGA is the doctor’s overall rating of how active the eczema is, from 0 (clear) to 4 (severe).
  • Have at least 10 % of your body surface area affected by eczema, measured as Body Surface Area (BSA) involvement, at both the screening and baseline visits.
  • Report an average daily peak itch (pruritus) score of 4 or higher on a 0‑10 Numeric Rating Scale (NRS) during the week before randomization. This scale measures how strong your itch feels.
  • Within the past 6 months, have shown an insufficient response to topical medicines, meaning the rash did not improve to mild or clear despite using strong steroid creams, ultra‑potent steroid creams, or topical calcineurin inhibitor creams for the required time periods.
  • Be able to stop any prohibited systemic (body‑wide) eczema treatments and complete a safe “wash‑out” period before randomization, as judged by the study doctor.
  • Begin using a moisturizer twice daily from the time you sign the consent form, continue it for at least 7 consecutive days before randomization, and keep using it throughout the study.
  • If you are a woman who could become pregnant, have a negative pregnancy test result during the screening period.
  • Agree to use effective contraception (birth control) from signing the consent form until 6 months after the last study dose, and do not donate or freeze sperm or eggs during this time.
  • Voluntarily sign the Informed Consent Form (ICF) and be able to attend all required study visits and follow the study procedures.
  • If you are under 18 years old, a parent or legal guardian must also sign the consent form, and you must give your own written or verbal agreement (assent) to take part.

Who cannot join the trial?

40 criteria

  • Body weight less than 30 kilograms (about 66 pounds).
  • Use of any biologic medicine (for example, drugs that target the immune system such as IL‑31/Nemolizumab) within the last 10 weeks or for a period longer than five times the drug’s half‑life.
  • Use of targeted inhibitors (such as JAK inhibitors), oral or intravenous steroids, cyclosporine, other immune‑suppressing medicines (like methotrexate, mycophenolate mofetil, azathioprine), PDE4 inhibitors, ultraviolet (UV) light therapy, or systemic herbal medicines for eczema within the last 4 weeks.
  • Use of any topical eczema treatment (including steroid creams, calcineurin inhibitor creams, antibiotic creams, or herbal creams) within the last 1 week.
  • Receiving allergy shots (allergen‑specific immunotherapy) within the last 6 months.
  • Having received a live or weakened‑live vaccine within the last 3 months or planning to receive one during the study.
  • Participating in another drug study within the last 3 months (or for a period longer than five drug half‑lives) or planning to join another study while this one is ongoing.
  • Previous use of medicines that block the interleukin‑4 receptor alpha (IL‑4Rα) or interleukin‑13 (IL‑13) (such as dupilumab, tralokinumab, lebrikizumab) if they did not work or caused serious side effects.
  • Having taken part in a previous MG‑K10 clinical trial.
  • Receiving oral or IV antibiotics, antivirals, or antifungal drugs within the last 4 weeks, or currently having signs of infection such as fever, cough, painful urination, abdominal pain, diarrhea, or infected skin wounds.
  • Having active tuberculosis (TB) or a past TB infection that was not fully treated, or a recent chest X‑ray/CT scan that suggests TB; TB screening is required before enrollment.
  • Having an active parasitic infection or being at high risk for one, unless tests prove there is no infection.
  • Laboratory test results that show any of the following problems:
    • Very low white blood cells called neutrophils (ANC < 1.2 × 10⁹/L).
    • Liver enzymes (AST, ALT) or bilirubin more than twice the normal upper limit.
    • Kidney test (creatinine) more than twice the normal upper limit and judged important by the doctor.
    • Low platelet count (< 75 × 10⁹/L).
    • Any other lab abnormality that the doctor feels makes participation unsafe.
    • Abnormal heart test (12‑lead ECG) that the doctor considers risky, such as a QT interval longer than 500 milliseconds.
    • Active hepatitis or positive tests for hepatitis B (HBsAg or HBcAb with HBV‑DNA) or hepatitis C (positive antibodies with HCV RNA).
    • Human immunodeficiency virus (HIV) infection or a positive HIV antibody test.
    • Positive test for syphilis (Treponema pallidum antibodies) unless confirmatory tests (RPR or TRUST) are negative.
    • History of alcohol or drug abuse within the past 2 years, defined as drinking more than 14 standard units of alcohol per week.
    • Having another active skin condition that could interfere with eczema evaluation, such as psoriasis or lupus.
    • Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
    • Any other medical condition that the doctor believes makes participation inappropriate.
    • Known allergy to any ingredient of the study medication.
    • Inability to tolerate blood draws or a strong fear of needles (needle phobia).
    • Other health problems that would require systemic steroids or frequent medical monitoring.
    • Significant, uncontrolled medical disorders, such as:
      • Severe heart disease (e.g., heart failure class III or worse).
      • Severe lung disease.
      • Serious gastrointestinal, liver, kidney, blood, nervous system, or psychiatric illnesses that are not stable.
      • Life expectancy less than 3 months.
      • Uncontrolled diabetes (HbA1c ≥ 9%).
      • Severe kidney disease requiring dialysis.
      • Advanced liver disease (Child‑Pugh class B or C).
      • Neurologic conditions such as demyelinating disease.
      • Active autoimmune diseases like lupus, inflammatory bowel disease, or rheumatoid arthritis.
      • Eye diseases that the doctor thinks are unsuitable for the study, such as atopic keratoconjunctivitis affecting the cornea.
      • Planning to have major surgery (inpatient or outpatient) during the study period.
      • Having any cancer diagnosed within the last 5 years, except for certain early cancers that have been completely removed and have not returned for at least 3 years (such as in‑situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma).
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Investigated drugs

MG-K10 Humanized Monoclonal Antibody is a laboratory‑made protein that is designed to attach to specific parts of the immune system that cause skin inflammation in atopic dermatitis. In this study, participants receive the medication as a solution for injection that is given under the skin (subcutaneous injection). The goal of the treatment is to reduce the redness, itching, and swelling associated with moderate‑to‑severe eczema, helping the skin become clearer and more comfortable.

What is already known about the treatment

  • Placebo

    The placebo is given as a subcutaneous injection using the same pre‑filled syringe as the active drug, but it contains no medicine. It is used in clinical trials to compare the effect of the real drug against an inactive substance. The placebo has no therapeutic use and is not approved for any condition. Its purpose is to help researchers see if the test drug works better than doing nothing.

  • MG‑K10 Humanized Monoclonal Antibody

    MG‑K10 is administered by a subcutaneous injection of a 600 mg solution in a pre‑filled syringe. It is an investigational humanized monoclonal antibody currently being studied in Phase III trials and is not yet approved for general use. The drug is designed to treat moderate‑to‑severe atopic dermatitis by blocking a specific immune signal that causes skin inflammation. It belongs to the class of immunomodulating monoclonal antibodies.

Investigated diseases

Moderate-to-Severe Atopic Dermatitis - Atopic dermatitis is a chronic inflammatory skin condition that causes itchy, red, and scaly patches. In the moderate-to-severe form, the rash often covers large body areas and may affect the face, hands, and folds. The disease follows a relapsing‑remitting pattern, with periods of flare‑ups followed by partial improvement. Skin barrier damage and immune activation contribute to ongoing inflammation. Triggers such as allergens, stress, or temperature changes can worsen symptoms. Over time, the condition may become more persistent and affect quality of life.
Trial detailsLast updated 6 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2025-525022-35-00Protocol codeMG-K10-AD-202Estimated enrolment368 patientsSponsorHunan Mabgeek Biotech Co. Ltd.

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