A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).

NCT ID: NCT06315426

Last Updated: 2025-04-25

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-24

Study Completion Date

2025-10-31

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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Conditions

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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 responder 1

Group Type EXPERIMENTAL

GR1802 injection

Intervention Type BIOLOGICAL

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Interleukin-4 receptor responder 2

Group Type EXPERIMENTAL

GR1802 injection

Intervention Type BIOLOGICAL

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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GR1802 injection

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily sign the informed consent form.
2. Seasonal allergic rhinitis has been prevalent for at least 2 years.
3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
4. Positive SPT or serum-specific IgE test results.
5. Symptom severity scores for the season met the enrollment criteria.

Exclusion Criteria

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
3. Subjects with poorly controlled recent asthma conditions.
4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
6. Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zheng Liu, PHD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Hebei Petro China Central Hospital

Langfang, Hebei, China

Site Status

Central Hospital of Qinghe County

Xingtai, Hebei, China

Site Status

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Site Status

Jingzhou Central Hospital

Jingzhou, Hubei, China

Site Status

The Central Hospital of Wuhan

Wuhan, Hubei, China

Site Status

Wuhan Union Hospital of China

Wuhan, Hubei, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Shandong Second Provincial General Hospital

Jinan, Shandong, China

Site Status

Liaocheng People's Hospital

Liaocheng, Shandong, China

Site Status

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Site Status

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status

Xi'an Daxing Hospital

Xi’an, Shanxi, China

Site Status

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Site Status

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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GR1802-011

Identifier Type: -

Identifier Source: org_study_id

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