Allergic Rhinitis
Conditions
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.
Interventions
BIOLOGICALGR1802 injection
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
BIOLOGICALPlacebo
Placebo
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Adverse events (AEs) | up to 12 weeks | Incidence of AEs. |
| Immunogenicity characteristics | up to 12 weeks | Positive rate of ADA(anti-drug antibody) testing |
| 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. |
Countries
China
Outcome results
None listed