A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).
- Conditions
- Allergic Rhinitis
- Interventions
- Biological: GR1802 injectionBiological: Placebo
- Registration Number
- NCT06315426
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- Voluntarily sign the informed consent form.
- Seasonal allergic rhinitis has been prevalent for at least 2 years.
- Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
- Positive SPT or serum-specific IgE test results.
- Symptom severity scores for the season met the enrollment criteria.
Main
- Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
- Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
- Subjects with poorly controlled recent asthma conditions.
- Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
- Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interleukin-4 receptor responder 1 GR1802 injection - Placebo Placebo - Interleukin-4 receptor responder 2 GR1802 injection -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Adverse events (AEs) up to 12 weeks Incidence of AEs.
Change from Baseline in rTNSS Over 4 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.
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores week2、4 The RQLQ is used to measure the problems that adults with rhinoconjunctivitis experience in their daily lives. It has 28 questions in 7 domains. The total score is the sum of the 7 domain scores, with higher scores being associated with poorer quality of life.
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores) week 2、4 TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms.
Change from Baseline in rTOSS( reflective total ocular symptom scores) Over 2、4 weeks TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms.
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores) week 2、4 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.
Change from baseline in VAS(Visual Analog Scale) score week2、4 Patients marked the score corresponding to the severity of the current overall AR symptoms by drawing a line on a 0-10 cm scale，the higher the score, the worse the symptoms.
Immunogenicity characteristics up to 12 weeks Positive rate of ADA(anti-drug antibody) testing
Trial Locations
- Locations (15)
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
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong Second Provincial General Hospital
🇨🇳Jinan, 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
🇨🇳Chendu, Sichuan, China