Allergic Rhinitis, Seasonal
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.
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)
Masking description
Part one subjects received open-label treatment. Part two subjects received double-blind treatment.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 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.Positive for allergens associated with seasonal allergic rhinitis. 3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past. 4. Weight≥30kg. 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 |
|---|---|---|
| Adverse events (AEs)(Part One) | up to 12 weeks | — |
| Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two) | up to 2 weeks | Scores range from 0 to 12, with higher scores indicating more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two) | week 2、4 | Scores range from 0 to 12, with higher scores indicating more severe symptoms. |
| Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two) | week 2、4 | Scores range from 0 to 9, with higher scores indicating more severe symptoms. |
| Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two) | up to 2、4 weeks | Scores range from 0 to 9, with higher scores indicating more severe symptoms. |
| Incidence of ADAs(Part One/Two) | up to 12 weeks | — |
| drug concentration、Ctrough(Part One/Two) | up to 12 weeks | — |
| Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two) | week2、4 | There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6). |
| Percentage Change from Baseline in rTNSS(Part One/Two) | up to 2、4 weeks | Scores range from 0 to 12, with higher scores indicating more severe symptoms. |
Countries
China
Contacts
Primary Contactliaison officer
Outcome results
None listed