Actively Recruiting
Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma
Led by Shanghai Mabgeek Biotech.Co.Ltd · Updated on 2025-04-17
504
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 75 years old, male or female, weighing at least 30 kg
- Diagnosed with asthma for at least 1 year and meeting 2024 GINA guideline criteria
- Using moderate to high dose inhaled corticosteroids combined with at least one control drug for at least 2 months before screening, with stable treatment for at least 1 month before baseline
- Forced expiratory volume in one second (FEV1) at screening and baseline less than or equal to 80% of predicted for adults or less than 90% for adolescents
- Asthma Control Questionnaire-5 (ACQ-5) score of 1.5 or higher at screening and baseline
- Experienced at least 1 acute asthma exacerbation requiring systemic glucocorticoids or hospitalization/emergency treatment within 12 months before screening
- Positive bronchodilator test within 24 months prior to screening showing at least 12% and 200 mL increase in FEV1
- Adolescents aged 12 to under 18 and their partners agree to use effective contraception from informed consent until 6 months after last drug administration
- Ability to understand study procedures, willing to sign informed consent, and capable of completing study questionnaires
You will not qualify if you...
- Known allergy or hypersensitivity to the investigational product or its ingredients
- Required systemic glucocorticoid therapy or hospitalization/emergency treatment for asthma exacerbation within 1 month prior to screening
- Received intravenous immunoglobulin or allergen-specific immunotherapy within 1 month prior to drug administration
- Underwent major surgery within 8 weeks before screening or scheduled major surgery during the study
- History of substance abuse or illicit drug use
- Any other condition judged by the investigator to affect safety or study integrity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
L
lipeng.liu L lipeng.liu, bachelor 02151371305 lipeng.liu@mabgeek.com, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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