Testing MG-K10 for treating moderate to severe asthma

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Adolescent and Adult Patients With Moderate-to-Severe Asthma

This study is testing if a new injection called MG-K10 can help people aged 12 to 75 with moderate to severe asthma breathe better over a year.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd (industry)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06837922 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of MG-K10, a humanized monoclonal antibody injection, in patients aged 12 to 75 with moderate to severe asthma. The study will enroll 504 participants who will receive either MG-K10 or a placebo through multiple subcutaneous injections over a treatment period of 52 weeks, following a structured screening and lead-in phase. The trial is designed to be randomized and double-blind to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 12 to 75 with a diagnosis of moderate to severe asthma who have been on a stable treatment regimen for at least two months.

Not a fit: Patients with mild asthma or those not currently on a moderate-high dose of inhaled corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve asthma management and quality of life for patients with moderate to severe symptoms.

How similar studies have performed: Previous studies of monoclonal antibodies for asthma have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Inclusion criteria:

1. Age between 12\~75 years old (including the critical value), male and female, weight ≥ 30kg;
2. Diagnosed with asthma for at least 1 year and current disease status that meets the diagnostic criteria of the 2024 GINA guidelines, and:

1\) Subjects have received moderate-high dose ICS therapy for at least 2 consecutive months before screening (see Appendix 5 for details, fluticasone propionate ≥250 μg twice a day, or an equivalent dose of ICS, no more than 2000 μg/day or equivalent dose of fluticasone propionate) combined with 1 control drug (such as LABA, LTRA, LAMA or extended-release theophylline), and maintained a stable treatment regimen and dose therapy for ≥ 1 month before baseline. Subjects using the third control drug can also participate in the study, but the subjects must also use the third control drug for at least 2 consecutive months before screening, and maintain a stable treatment regimen and dose treatment ≥ 1 month before baseline; 2) 1-second forced expiratory volume (FEV1) before bronchodilator use at the screening and baseline visits, measured ≤ 80% of the normal predicted value for adults and 90% of the normal predicted value ≤ for adolescents; 3) Asthma Control Questionnaire-5 (ACQ-5) score ≥ 1.5 points at the screening and baseline visits; 4) Must have experienced ≥ 1 acute exacerbation event within 12 months prior to screening: need to receive 1 ≥ systemic glucocorticoids (oral or intravenous) treatment due to asthma exacerbation or need hospitalization/emergency treatment; 5）A positive bronchodilator test (a ≥12% increase in FEV1 after inhalation of bronchodilators and an absolute increase in FEV1 ≥200 mL) will be acceptable for bronchodilator test results within 24 months prior to screening； Positive bronchodilator test (after inhaling a bronchodilator, the forced expiratory volume in one second (FEV1) increases by ≥12%, and the absolute value of FEV1 increases by ≥200 mL). The results of the bronchodilator test conducted within 24 months before screening are acceptable.

3.The subjects (including adolescents aged 12 years old ≤ age \< 18 years old) agree that they themselves and their partners will adopt effective contraceptive measures from the signing of the Informed Consent Form (ICF) until 6 months after the last administration of the drug.

4.The subject and his/her guardian (applicable to adolescents aged 12 years old ≤ age \< 18 years old) are able to understand the procedures and methods of this study, willing to sign the Informed Consent Form, strictly abide by the clinical research protocol to complete the study, and capable of independently completing the study-related questionnaires.

Exclusion criteria:

1. Subjects with known hypersensitivity to the investigational product or its excipients;
2. Subjects who, within 1 month prior to screening and drug administration, have required systemic glucocorticoid therapy (oral or intravenous) for asthma exacerbation at least once, or have required hospitalization/emergency treatment due to asthma exacerbation.
3. Subjects who, within 1 month prior to screening and drug administration, have required at least one course of systemic glucocorticoid therapy (oral or intravenous administration) for asthma exacerbation, or have required hospitalization or emergency treatment due to asthma exacerbation.
4. Subjects who have received systemic glucocorticoid therapy from 1 month before screening until drug administration (excluding those with topical, ophthalmic, or intranasal glucocorticoid use)
5. Subjects who have received intravenous immunoglobulin (IVIG) therapy or allergen-specific immunotherapy (SIT) within 1 month prior to drug administration.
6. Subjects who have undergone major surgery within 8 weeks prior to screening have scheduled major surgery during the study period, including inpatient and day-case outpatient procedures.
7. Subjects with a history of substance abuse or illicit drug use.
8. Subjects with any other conditions that, in the investigator's judgment, may compromise subject safety or trial integrity.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: lipeng.liu L lipeng.liu, bachelor 02151371305 [e-mail], bachelor

Conditions: Asthma