A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial aimed at evaluating the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SHR-1819 injection in patients with Seasonal Allergic Rhinitis (SAR).

Eligibility criteria

Qualifiers

Age 18 to 75 years (inclusive) at the time of signing the Informed Consent Form, of any sex;

Meet the diagnostic criteria for Seasonal Allergic Rhinitis (SAR) as defined in the "Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)", with or without allergic conjunctivitis;

The investigator assesses that the participant has had a poor response to intranasal corticosteroids and/or other medications for allergic rhinitis (antihistamines, leukotriene receptor antagonists, etc.) during the same pollen season in previous years;

Participants exhibit an immunoglobulin E-mediated hypersensitivity reaction to at least one seasonal pollen allergen;

Disqualifiers

At screening or within 2 weeks prior to the screening visit, the participant has other active rhinitis besides SAR;

At screening or within 2 weeks prior to the screening visit, there may be other nasal comorbidities or concurrent diseases/conditions that could affect the efficacy assessment, acute/chronic sinusitis, or upper respiratory tract infection;

Has glaucoma, cataract, ocular herpes simplex, other ocular infections such as infectious conjunctivitis, acute conjunctivitis, or acute keratitis at screening;

History of Vernal Keratoconjunctivitis (VKC) and/or Atopic Keratoconjunctivitis (AKC) within 6 months prior to the screening visit;

Trial design

Treatments tested in this trial

  • SHR-1819 Injection
  • SHR-1819 Injection Placebo

Treatment groups

196 Participants
are divided into 2 treatment groups