Injection of MG-K10 antibody for treating atopic dermatitis

Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis

This study is testing if a new antibody treatment can help adults with moderate to severe eczema who haven't found relief with other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd (Government)
• Drugs / interventions: immunotherapy, methotrexate
• Locations: 1 site (Beijing)
• Trial ID: NCT06026891 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the effectiveness and safety of MG-K10, a humanized monoclonal antibody, in adults with moderate to severe atopic dermatitis who have not responded adequately to local therapies. The study involves approximately 498 participants who will receive subcutaneous injections every four weeks for a total of 52 weeks. It includes a screening period, a double-blind treatment phase, a maintenance period, and a follow-up phase to assess outcomes. The trial is designed to compare the effects of MG-K10 against a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with moderate to severe atopic dermatitis who have not achieved adequate control with topical or systemic therapies.

Not a fit: Patients with other active skin diseases or those who have not been diagnosed with atopic dermatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved management for patients suffering from moderate to severe atopic dermatitis.

How similar studies have performed: Other studies involving monoclonal antibodies for atopic dermatitis have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. age 18-75 years (inclusive of 18 and 75 years), both sexes;
2. patients with AD diagnosed in accordance with the American Academy of Dermatology Consensus Criteria (2014), with a pre-screening diagnosis of AD or history of eczema for ≥1 year, and the following:

   * Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visit;
   * Investigator's Overall Assessment (IGA) ≥3 points at screening and baseline visit;
   * BSA ≥10% of area of AD involvement at screening and baseline visit
   * Weekly mean of peak daily itch NRS score ≥4 at randomization;
3. the patient had an inadequate treatment effect on topical medication or systemic therapy within 6 months prior to the screening visit, or the use of topical medication or systemic therapy was medically inappropriate
4. negative screening blood pregnancy test results in women of childbearing age;

Exclusion Criteria.

1. subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
2. Patients with ocular disease that, in the judgment of the Investigator, makes enrollment in the study inappropriate, e.g., past history of atopic keratoconjunctivitis with corneal involvement; if the Investigator is unable to make a determination, a diagnosis will be made by an ophthalmologist;
3. those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;
4. Subjects with the following conditions:

   * Persons who have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer); Targeted inhibitors (e.g., JAK inhibitors, etc.), systemic glucocorticoids, cyclosporine and other immunosuppressants (e.g., methotrexate, mycophenolate mofetil \[MMF\], and azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet light therapy, and systemic herbal medicine for AD within 4 weeks prior to randomization;
   * Has received topical glucocorticosteroids, topical calcineurin phosphatase inhibitors, antibiotic compound cream, and topical herbal therapy for AD within 1 week before randomization;
   * Has received allergen-specific immunotherapy within 6 months prior to randomization;
   * Live/live attenuated vaccination within 3 months prior to randomization or planned for the duration of the study;
   * Participation in a clinical study of another drug in the 3 months or 5 half-lives, whichever is longer, prior to randomization or planning to participate in a clinical study of another drug during the study period;
   * Subjects with prior use of an interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody drug who, in the judgment of the investigator, have developed drug resistance or drug-related serious AE;
   * Previous participation in the MG-K10 clinical trial;
5. evidence of active tuberculosis, or previous evidence of active tuberculosis without appropriate documented treatment; chest X-ray (frontal and lateral) or CT, etc. within 3 months prior to/surrounding the screening period suggesting the presence of active tuberculosis infection;
6. women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jianzhong Zhang, Medical Ph.D — Feking University People's Hospital
• Study coordinator: xiaofeng Cai, bachelor

Conditions Atopic Dermatitis