A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).
NCT ID: NCT06315426
Last Updated: 2025-04-25
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2024-03-24
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Interleukin-4 receptor responder 1
GR1802 injection
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Interleukin-4 receptor responder 2
GR1802 injection
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo
Placebo
Placebo
Interventions
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GR1802 injection
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Genrix (Shanghai) Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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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
Central Hospital of Qinghe County
Xingtai, Hebei, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Second Provincial General Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Xi'an Daxing Hospital
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Countries
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Other Identifiers
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GR1802-011
Identifier Type: -
Identifier Source: org_study_id
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