Actively Recruiting
Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Study Evaluating MG-K10 Humanized Monoclonal Antibody Injection for Seasonal Allergic Rhinitis
Led by Shanghai Mabgeek Biotech.Co.Ltd · Updated on 2025-04-18
160
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MG-K10 humanized monoclonal antibody injection in a multicenter, randomized, double-blind, placebo-controlled Phase II/III seamless clinical study for people with seasonal allergic rhinitis. The study aims to assess the drug's effectiveness, safety, how it moves through and acts in the body, and its potential to trigger immune responses. Around 120 patients in stage II and 106 patients in stage III with seasonal allergic rhinitis are included, all receiving a single dose. Participants receive either MG-K10 or a placebo as a single dose during the study. The study includes a screening period lasting one week, a four-week double-blind treatment period, and a two-week safety follow-up. The design ensures patients and researchers do not know which treatment is given during the treatment phase to fairly compare outcomes. During the study, patients have symptom scores recorded and monitored to evaluate changes in nasal symptoms. Researchers will assess the primary outcome of change in mean reflective total nasal symptom score (rTNSS) after two weeks, along with secondary outcomes at two and four weeks. Patients are followed closely for safety during and after treatment, with a total observation period of seven weeks from screening through follow-up.
CONDITIONS
Brief 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, male or female
- Diagnosed with seasonal allergic rhinitis for 2 or more years
- Positive skin prick test or serum specific IgE related to allergic rhinitis within 1 year before randomization
- Used nasal corticosteroids or other SAR drugs during previous pollen season with poor symptom control
- Reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS) meeting specified thresholds at screening and baseline
- Agree to use effective birth control during the study period 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 components
- Planned travel outside pollen areas for 48 hours or more during screening and treatment
- Significant changes in allergen exposure at home or work that may affect study results
- Limited outdoor activities interfering with efficacy evaluation
- Previous poor response to anti-IL-4Rα monoclonal antibody drugs
- Use of antihistamines within 4 days before randomization
- Use of leukotriene receptor antagonists or mast cell stabilizers within 1 week before randomization
- Recent use of systemic corticosteroids or Chinese medicine for AR treatment within specified timeframes
- New or unstable inhaled glucocorticoid therapy within 4 weeks before randomization
- Use of systemic immunosuppressants or biologic therapies within half-life periods before randomization
- Participation in prior MG-K10 clinical trials
- Recent live or attenuated vaccines within 3 months before randomization
- Recent immunotherapy or plans to start immunotherapy during the study
- Nasal or sinus surgery within 1 year before randomization
- History of organ or stem cell transplantation
- Nasal conditions that may affect efficacy evaluation
- Recent sinusitis, nasal infection, or upper respiratory infection
- Presence of nasal tumors
- Recent infections requiring treatment
- Certain allergic rhinitis types under specific conditions
- History or presence of malignancies within 5 years except certain skin and cervical cancers
- History or evidence of high-risk cardiovascular disease
- Certain eye conditions affecting symptom evaluation
- Active or suspected tuberculosis or worm infections
- Severe herpes virus infections
- Severe diseases in major organ systems affecting safety or efficacy
- Immunosuppression or history of opportunistic infections
- Significant laboratory abnormalities
- Pregnant or breastfeeding women or positive pregnancy test
- Any other reason deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 week
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive a single dose of either MG-K10 humanized monoclonal antibody injection or placebo during the double-blind treatment period.
Weekly visits for up to 4 weeks
Duration - 2 weeks
Participants are monitored for safety after the treatment period ends.
1 to 2 visits during follow-up
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
C
chao deng, bachelor
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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