A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• At the time of signing the informed consent form, the age is 18 to 75 years old.

• Meet the diagnostic criteria for seasonal allergic rhinitis (SAR) as defined in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have a disease duration of at least 2 years.

• At the screening visit, the investigator assesses that the subject had poor efficacy with intranasal glucocorticoids and/or other medications for allergic rhinitis (antihistamines, leukotriene receptor antagonists, etc.) during the same pollen season in the past.

• The subject has an immunoglobulin E (IgE)-mediated hypersensitivity to at least one pollen allergen in the current season or the same period, which can be confirmed based on the skin prick test (SPT) and/or serum specific IgE results during the screening period (test results within 1 year before randomization are acceptable).

• Willing and able to complete the patient diary as required by the protocol during the study period.

• Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential agree to use the contraceptive measures specified in the protocol from the signing of the ICF until 3 months after the last administration.

Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xiaoyan Bai
xiaoyan.bai.xb1@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-08-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Experimental: SHR-1819 Injection Dose 1 Group
Experimental: SHR-1819 Injection Dose 2 Group
Placebo_comparator: SHR-1819 Injection Placebo Group
Related Therapeutic Areas
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov