A Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

Detailed Description
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AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden. AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset < 4 days/week, or < 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.

Official Title
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The Efficacy and Safety of CM310 Injection in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial (IIT) Study

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Biological: Interleukin-4 receptor responders 1
* Biological: Interleukin-4 receptor responders 2
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily sign the informed consent form. Exclusion Criteria: Have any condition that are not suitable for participating in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interleukin-4 receptor responders 1<br>Interleukin-4 receptor was injected subcutaneously, once every two weeks. | Biological: Interleukin-4 receptor responders 1<br>* Interleukin-4 receptor was injected subcutaneously.<br>|
| Experimental: Interleukin-4 receptor responders 2<br>Interleukin-4 receptor was injected subcutaneously, once a week. | Biological: Interleukin-4 receptor responders 2<br>* Interleukin-4 receptor was injected subcutaneously.<br>|
| Placebo Comparator: Controls<br>Placebo was injected subcutaneously. | Biological: Placebo<br>* Placebo was injected subcutaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. | Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. | up to week 2 |