Actively Recruiting
Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis
Led by Shanghai Mabgeek Biotech.Co.Ltd · Updated on 2025-04-18
160
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, randomized, double-blind, placebo-controlled Phase II/III seamless clinical study evaluating the efficacy, safety, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, and immunogenicity of MG-K10 humanized monoclonal antibody injection in the treatment of seasonal allergic rhinitis
CONDITIONS
Official Title
Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old, male or female
- Diagnosed with seasonal allergic rhinitis for 2 or more years
- Positive skin prick test or serum specific IgE within 1 year before randomization
- Used nasal corticosteroids or other SAR drugs during the previous pollen season with poorly controlled symptoms
- iTNSS score of 6 or more at screening and baseline, with specified symptom scores
- Agree to use highly effective birth control during the study if fertile
- Able to understand and comply with study requirements and provide informed consent
You will not qualify if you...
- Allergy to the study drug or its excipients
- Travel plans of 48 hours or more from pollen areas during screening and treatment
- Significant changes in allergen exposure at home or work during the trial
- Limited outdoor activities (no outdoor activity 1 or more days per week)
- Previous poor response to anti-IL-4Rα monoclonal antibody drugs for allergic rhinitis
- Use of antihistamines within 4 days prior to randomization
- Use of leukotriene receptor antagonists or membrane stabilizers within 1 week before randomization
- Use of systemic corticosteroids or Chinese medicine for AR within specified timeframes before randomization
- Recent start or unstable inhaled glucocorticoid therapy
- Use of immunosuppressants or biologics within specific half-lives before randomization
- Participation in MG-K10 clinical trials
- Recent live/attenuated vaccine or immunotherapy
- Nasal or sinus surgery within 1 year
- History of organ transplantation
- Other nasal comorbidities affecting efficacy evaluation
- Recent sinusitis, nasal infection, or upper respiratory infection
- Malignant or benign nasal tumors
- Recent infections requiring systemic treatment
- Certain perennial allergic rhinitis cases
- History of lymphoproliferative diseases or recent malignancies
- High-risk cardiovascular disease
- Eye conditions affecting symptom evaluation
- Active or suspected tuberculosis
- Recent or suspected worm infections
- Severe herpes virus infection history
- Severe systemic diseases affecting safety or efficacy
- Known or suspected immunosuppression
- Significant laboratory abnormalities
- Pregnant or lactating women
- Other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100009
Actively Recruiting
Research Team
L
lipeng liu, bachelor
CONTACT
C
chao deng, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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