Zhongnan Hospital of Wuhan university
Wuhan, Hubei, 430000, China
Location status: Recruiting
Recruiting
NCT Number: NCT07154342
A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
- 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 serum-specific IgE test results.
- Symptom severity scores for the season met the enrollment criteria.
Main Exclusion Criteria:
- 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.
Treatment and study plan
GR1802 injection
BiologicalRecombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo
BiologicalPlacebo
Primary outcomes
-
Change from Baseline in rTNSS( reflective total nasal symptom scores)
Time frame: up to 2 weeks
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Secondary outcomes
-
Change from Baseline in rTOSS( reflective total ocular symptom scores)
Time frame: up to 2、4 weeks
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
-
Change from Baseline in rTNSS
Time frame: up to 4 weeks
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
-
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)
Time frame: 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)
Time frame: week 2、4
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
-
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores
Time frame: week2、4
There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6).
-
Adverse events (AEs)
Time frame: up to 12 weeks
-
Incidence of ADAs
Time frame: up to 12 weeks
-
Ctrough
Time frame: up to 12 weeks
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Industry
Registry information
Official study title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 4, 2025
- Registry last updated
- Sep 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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