A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).

Phase 2Active Not RecruitingNCT06315426

Genrix (Shanghai) Biopharmaceutical Co., Ltd.240 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Allergic Rhinitis

Interventions

GR1802 injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (15)

Hebei Petro China Central Hospital

Langfang, Hebei, China

Central Hospital of Qinghe County

Xingtai, Hebei, China

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

The Central Hospital of Wuhan

Wuhan, Hubei, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Second Provincial General Hospital

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

...and 5 more locations

Outcomes

Primary Outcomes

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.

Time frame: Over 2 weeks

Secondary Outcomes

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.

Time frame: Over 2、4 weeks

Change from Baseline in rTNSS

Time frame: Over 4 weeks

Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: week2、4

Adverse events (AEs)

Incidence of AEs.

Time frame: up to 12 weeks

Immunogenicity characteristics

Positive rate of ADA(anti-drug antibody) testing

Time frame: up to 12 weeks