Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

NCT ID: NCT06300203

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2026-06-30

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.

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Interleukin-4 receptor responders

Interleukin-4 receptor was injected subcutaneously.

Group Type EXPERIMENTAL

Interleukin-4 receptor responders

Intervention Type BIOLOGICAL

Interleukin-4 receptor was injected subcutaneously.

Placebo

Placebo was injected subcutaneously.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo was injected subcutaneously.

Interventions

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Interleukin-4 receptor responders

Interleukin-4 receptor was injected subcutaneously.

Intervention Type BIOLOGICAL

Placebo

Placebo was injected subcutaneously.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luo Zhang

Role: STUDY_CHAIR

Beijing Tong-Ren hospital

Locations

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Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo Zhang

Role: CONTACT

+86-13910830399

Facility Contacts

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Luo Zhang

Role: primary

+86-13910830399

Other Identifiers

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CM310_IIS_SAR07

Identifier Type: -

Identifier Source: org_study_id

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