Clinical trial NCT06315426: A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in rTNSS( reflective total nasal symptom scores)
timeFrame: Over 2 weeks
Secondary outcomes:
measure: Change from Baseline in rTOSS( reflective total ocular symptom scores)
timeFrame: Over 2、4 weeks
measure: Change from Baseline in rTNSS
timeFrame: Over 4 weeks
measure: Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)
timeFrame: week 2、4
measure: Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)
timeFrame: week 2、4
measure: Change from baseline in VAS(Visual Analog Scale) score
timeFrame: week2、4
measure: Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores
timeFrame: week2、4
measure: Adverse events (AEs)
timeFrame: up to 12 weeks
measure: Immunogenicity characteristics
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
state: Hebei
city: Xingtai
country: China
facility: Central Hospital of Qinghe County
state: Hebei
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Second Provincial General Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Chendu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
Study officials:
affiliation: Tongji Hospital
name: Zheng Liu, PHD
role: PRINCIPAL_INVESTIGATOR
References: