Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate SHR-1819 Injection for Seasonal Allergic Rhinitis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-09-03
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SHR-1819 injection in treating adults with seasonal allergic rhinitis, a condition causing nasal allergy symptoms during pollen seasons. This phase II study is randomized, double-blind, and placebo-controlled, aiming to understand how the drug affects nasal symptoms and its behavior in the body. Participants are randomly assigned to receive one of two doses of SHR-1819 injection or a placebo. The study includes a treatment period lasting up to 4 weeks, where the impact on nasal symptoms is closely monitored. The trial also tracks safety by recording any adverse events for up to 12 weeks. Throughout the study, participants will complete daily symptom diaries and undergo assessments to measure changes in nasal symptoms using a total nasal symptom score. Researchers will collect data on how the drug is processed in the body and monitor participants' safety. The total participation time may extend beyond the treatment period to capture all necessary outcome and safety information.
CONDITIONS
Brief 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 signing consent
- Diagnosed with seasonal allergic rhinitis according to Chinese guidelines, with or without allergic conjunctivitis, lasting at least 2 years
- Poor response to nasal glucocorticoids and/or other allergy medications during the current pollen season
- Confirmed IgE-mediated allergy to at least one pollen allergen by skin prick test or serum IgE within 1 year
- Willing and able to complete patient diaries as required
- Agree to use specified contraceptive measures if of childbearing potential or partner is
You will not qualify if you...
- Active rhinitis types other than seasonal allergic rhinitis within 2 weeks before screening
- Nasal conditions or diseases that could affect efficacy judgment, including nasal polyps, recent surgery, sinusitis, or infections
- Eye infections or conditions excluding allergic rhinitis symptoms
- Perennial allergic rhinitis to pet hair unless no current contact
- Severe asthma with high-dose inhaled steroids or unstable asthma treatment
- Recent asthma exacerbation requiring hospitalization within 3 months
- History of vernal or atopic keratoconjunctivitis within 6 months
- Recent use of leukotriene receptor antagonists, monoamine oxidase inhibitors, systemic steroids, immunosuppressants, or certain traditional medicines
- Recent start or planned immunotherapy during the study unless stable for 4 weeks before screening
- Recent participation in other clinical trials or vaccine studies
- Recent use of biological agents or systemic antimicrobial treatment
- Positive tests for HIV, syphilis, hepatitis C, or certain hepatitis B criteria
- Recent major surgery or diagnosis of active tuberculosis or immunosuppressive diseases
- History of recurrent or disseminated herpes infections
- History of malignant tumors except certain skin or cervical cancers
- Severe or poorly controlled chronic diseases
- Pregnant or breastfeeding women
- History of alcohol abuse within 6 months
- Any conditions affecting safety, efficacy evaluation, or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 weeks
Participants receive SHR-1819 injection or placebo as part of the study treatment for seasonal allergic rhinitis.
Weekly visits during treatment
Duration - Up to 8 weeks after treatment
Participants are monitored for safety and adverse events after treatment ends.
Approximately 3 follow-up visits
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
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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