A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR.
1 other identifier
interventional
240
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2024
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
March 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedApril 25, 2025
April 1, 2025
1.1 years
March 11, 2024
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in rTNSS( reflective total nasal symptom scores)
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.
Over 2 weeks
Secondary Outcomes (8)
Change from Baseline in rTOSS( reflective total ocular symptom scores)
Over 2、4 weeks
Change from Baseline in rTNSS
Over 4 weeks
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)
week 2、4
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)
week 2、4
Change from baseline in VAS(Visual Analog Scale) score
week2、4
- +3 more secondary outcomes
Study Arms (3)
Interleukin-4 receptor responder 1
EXPERIMENTALInterleukin-4 receptor responder 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Hebei Petro China Central Hospital
Langfang, Hebei, 065000, China
Central Hospital of Qinghe County
Xingtai, Hebei, 054800, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434000, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430000, China
Wuhan Union Hospital of China
Wuhan, Hubei, 430000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Shandong Second Provincial General Hospital
Jinan, Shandong, 250000, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zheng Liu, PHD
Tongji Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
March 24, 2024
Primary Completion
May 1, 2025
Study Completion
October 1, 2025
Last Updated
April 25, 2025
Record last verified: 2025-04