Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Last updated: September 20, 2025
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy

Common Cold

Rhinitis, Allergic, Perennial

Treatment

Placebo

Interleukin-4 receptor responders

Clinical Study ID

NCT06300203
CM310_IIS_SAR07
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntarily sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Have any condition that are not suitable for participating in this study.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 18, 2024
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100000
    China

    Active - Recruiting

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