Actively Recruiting
The Efficacy and Safety of Humanized Antibody Targeting the Interleukin-4 Receptor Alpha Subunit in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Standard Treatment: A Randomized, Double-Blind, Placebo-Controlled Study
Led by Beijing Tongren Hospital · Updated on 2025-09-25
120
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Seasonal allergic rhinitis (AR) is a common chronic nasal condition caused by an overreaction to allergens such as pollen, leading to symptoms like sneezing, a runny nose, itching, and nasal congestion. This condition often affects quality of life by causing fatigue and difficulty concentrating, and it may be linked with asthma in many patients. The study aims to evaluate a humanized antibody targeting the interleukin-4 receptor alpha subunit in people with uncontrolled seasonal allergic rhinitis who are already receiving standard treatment. Participants in this randomized, double-blind, placebo-controlled Phase 2 study will receive either a subcutaneous injection of the interleukin-4 receptor antibody or a placebo injection. The study will compare these treatments in their effect on symptoms of seasonal allergic rhinitis. The treatment period lasts up to 2 weeks, with ongoing monitoring to assess changes in nasal symptoms. Throughout the study, participants will report their nasal symptoms daily, focusing on changes from their baseline condition. Researchers will measure the average change in total nasal symptom scores by week 2 to evaluate the treatment's effects. The study includes safety monitoring and requires participants to provide informed consent. Total participant involvement spans the treatment and observation periods, ensuring thorough assessment of efficacy and safety.
CONDITIONS
Brief Title
Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
You will not qualify if you...
- Have any condition that is not suitable for participating in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants receive subcutaneous injections of either the interleukin-4 receptor antibody or placebo while continuing their standard treatment for seasonal allergic rhinitis.
Weekly visits for up to 2 weeks
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
L
Luo Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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