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Clinical Trials in China / NCT06315426
Active, not recruiting Phase 2

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

NCT06315426 · tracked via the Priya Life Science China tracker
Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd
Phase
Phase 2
Started
2024-03-24
Last updated
2025-04-25

Condition(s) studied

Allergic Rhinitis

Investigational drug(s) / intervention(s)

GR1802 injection →Placebo

GR1802 injection: Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Placebo: Placebo

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Main 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. Main 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.

Primary outcome measure(s)

  • Change from Baseline in rTNSS( reflective total nasal symptom scores) — Over 2 weeks
    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. The total score is 12, the higher the score, the worse the symptoms.

Trial sites (15)

FacilityCityRegionStatus
Hebei Petro China Central Hospital Langfang Hebei
Central Hospital of Qinghe County Xingtai Hebei
Zhengzhou Central Hospital Zhengzhou Henan
Jingzhou Central Hospital Jingzhou Hubei
The Central Hospital of Wuhan Wuhan Hubei
Wuhan Union Hospital of China Wuhan Hubei
Qilu Hospital of Shandong University Jinan Shandong
Shandong Second Provincial General Hospital Jinan Shandong
Liaocheng People's Hospital Liaocheng Shandong
Heping Hospital Affiliated to Changzhi Medical College Changzhi Shanxi
First Hospital of Shanxi Medical University Taiyuan Shanxi
Shanxi Bethune Hospital Taiyuan Shanxi
Xi'an Daxing Hospital Xi’an Shanxi
Yuncheng Central Hospital Yuncheng Shanxi
Chengdu Second People's Hospital Chengdu Sichuan

More Genrix (Shanghai) Biopharmaceutical Co., Ltd. trials in China

A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers. Starting soon
A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma Starting soon
A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Recruiting
A Study of GR1803 in Systemic Lupus Erythematosus Recruiting
GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma Active, not recruiting

Other trials for the same condition

Study on the Effect and Mechanism of Aescine Sodium in the Treatment of Allergic Rhinitis Starting soon
The Effect of Oral Probiotics on Allergic Rhinitis Symptoms and the Quality of Life Active, not recruiting
Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR Starting soon
Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis Recruiting
Intratonsillar Immunotherapy for Allergic Rhinitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06315426 on ClinicalTrials.gov ↗ ← All trials in China