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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Biological: Placebo; Biological: GR1802 injection

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China, 065000
      • Hebei Petro China Central Hospital
    • Xingtai, Hebei, China, 054800
      • Central Hospital of Qinghe County
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Zhengzhou Central Hospital
  • Hubei
    • Jingzhou, Hubei, China, 434000
      • Jingzhou Central Hospital
    • Wuhan, Hubei, China, 430000
      • Wuhan Union Hospital of China
    • Wuhan, Hubei, China, 430000
      • The Central Hospital of Wuhan
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250000
      • Shandong Second Provincial General Hospital
    • Liaocheng, Shandong, China, 252000
      • Liaocheng People's Hospital
  • Shanxi
    • Changzhi, Shanxi, China, 046000
      • Heping Hospital Affiliated to Changzhi Medical College
    • Taiyuan, Shanxi, China, 030000
      • First Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Bethune Hospital
    • Xi'an, Shanxi, China, 710000
      • Xi'an Daxing Hospital
    • Yuncheng, Shanxi, China, 044000
      • Yuncheng Central Hospital
  • Sichuan
    • Chendu, Sichuan, China, 610000
      • Chengdu Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo
Experimental: Interleukin-4 receptor responder 1	Biological: GR1802 injection; Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Experimental: Interleukin-4 receptor responder 2	Biological: GR1802 injection; Recombinant fully human anti-IL4Rα monoclonal antibody drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in rTOSS( reflective total ocular symptom scores)	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.	Over 2、4 weeks
Change from Baseline in rTNSS	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 4 weeks
Mean change from baseline in iTNSS(instantaneous 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.	week 2、4
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)	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.	week 2、4
Change from baseline in VAS(Visual Analog Scale) score	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.	week2、4
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores	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.	week2、4
Adverse events (AEs)	Incidence of AEs.	up to 12 weeks
Immunogenicity characteristics	Positive rate of ADA(anti-drug antibody) testing	up to 12 weeks

Collaborators and Investigators

• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Zheng Liu, PHD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: GR1802-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No