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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ Age between 12\

‣ 75 years old (including the critical value), male and female, weight ≥ 30kg;

⁃ 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.

• 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.

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
lipeng.liu L lipeng.liu, bachelor 02151371305 lipeng.liu@mabgeek.com, bachelor
lipeng.liu@mabgeek.com
02151371305
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2028-01-15
Participants
Target number of participants: 504
Treatments
Placebo_comparator: MG-K10 placebo
Every four weeks, subcutaneous injection ,total of 52W
Experimental: MG-K10 Humanized Monoclonal Antibody Injection
Every four weeks, subcutaneous injection ,total of 52W
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mabgeek Biotech.Co.Ltd

This content was sourced from clinicaltrials.gov