Actively Recruiting
A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-09-03
100
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.
CONDITIONS
Official Title
A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of consent
- Diagnosis of seasonal allergic rhinitis according to Chinese Guidelines, with or without allergic conjunctivitis, lasting at least 2 years
- Poor response to intranasal glucocorticoids and/or other allergy medications during the same pollen season in the past
- Confirmed IgE-mediated allergy to at least one pollen allergen this season or similar period by skin prick test or serum specific IgE
- Willing and able to complete a patient diary as required during the study
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use specified contraception from consent until 3 months after last dose
You will not qualify if you...
- Presence of other active rhinitis types excluding seasonal allergic rhinitis within 2 weeks prior to screening
- Nasal conditions or diseases that may affect efficacy judgment, including nasal polyps, recent nasal surgery, severe septal deviation, sinusitis, or upper respiratory infections
- Eye conditions like glaucoma, cataract, ocular herpes, infectious conjunctivitis, or keratitis unrelated to allergic rhinitis
- Perennial allergic rhinitis to pet hair unless no current contact with pets
- Severe asthma requiring high-dose inhaled glucocorticoids or recent asthma exacerbation needing hospitalization
- Recent initiation or unstable use of inhaled glucocorticoids for asthma
- Recent use of leukotriene receptor antagonists or certain nasal preparations less than 1 week before randomization
- Recent use of monoamine oxidase inhibitors, systemic glucocorticoids, immunosuppressants, traditional Chinese medicines for allergic rhinitis, or tricyclic antidepressants
- Recent or planned immunotherapy initiation within 4 weeks prior to screening
- Recent participation in other clinical trials or exposure to investigational drugs or devices
- Recent live vaccine use or participation in vaccine trials
- Recent use of other biological agents within 6 months
- Need for systemic antimicrobial treatment within 1 week prior to screening
- Positive tests for HIV, syphilis, hepatitis C, or active hepatitis B infection
- Recent major surgery or planned surgery during the study
- History of active tuberculosis or suspected immunosuppressive diseases
- History of recurrent or disseminated herpes infections
- History of malignant tumors except certain completely resected skin or cervical cancers
- Severe or uncontrolled chronic diseases
- Pregnant or lactating women
- History of alcohol abuse within 6 months
- Any condition or circumstance judged by the investigator to affect safety, efficacy evaluation, or compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
X
Xiaoyan Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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