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Not yet recruiting NCT07688772

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

Phase III Interventional Seasonal Allergic Rhinitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1819 Injection, SHR-1819 Injection Placebo.
Who it may be relevant to
Registry conditions: Seasonal Allergic Rhinitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug SHR-1819 Injection
    SHR-1819 injection.
  • Drug SHR-1819 Injection Placebo
    SHR-1819 injection placebo.

Primary outcome measures

  • Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment. [Time frame: 2 weeks.]
Secondary outcome measures (10)
  • Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 4 weeks of treatment. [Time frame: 4 weeks.]
  • Mean percent change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Mean percent change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Mean change from baseline in the daily AM reflective Total Nasal Symptom Score (AM rTNSS) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Mean change from baseline in the daily PM reflective Total Nasal Symptom Score (PM rTNSS) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Mean change and percent change from baseline in the daily pre-morning dose instantaneous Total Nasal Symptom Score (iTNSS) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Mean change from baseline in the daily/daily AM/daily PM/reflective individual nasal symptom scores (rhinorrhea, nasal congestion, nasal itching, and sneezing) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Mean change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score within 2 and 4 weeks of treatment. [Time frame: 2 and 4 weeks.]
  • Total number of days without nasal symptoms, without nasal congestion symptoms, and without any symptoms from the baseline visit to the end of Week 2 and Week 4 of treatment. [Time frame: 2 and 4 weeks.]

Eligibility criteria

Inclusion criteria

  • 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;
  • Willing and able to complete the patient diary as required by the protocol during the study; the participant voluntarily signs the Informed Consent Form (ICF) before any study-related procedures begin, can communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
  • Female participants of childbearing potential and male participants whose partners are women of childbearing potential must agree to use the contraceptive measures specified in the protocol from the signing of the ICF until 3 months after the last dose.

Exclusion criteria

  • 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;
  • Use of Monoamine Oxidase Inhibitors within 2 weeks prior to the screening visit;
  • Initiation of immunotherapy within 4 weeks prior to the screening visit or planned receipt of immunotherapy during the study period;
  • Receipt of an investigational drug or medical device treatment within 8 weeks or 5 half-lives (if the half-life is known) prior to the screening visit, whichever is longer. Participants who participated in a clinical study but only signed the Informed Consent Form (ICF), which can demonstrate screening failure and no drug administration, may be included;
  • Vaccination with or exposure to other live or live attenuated vaccines within 3 months prior to the screening visit, or participation in a vaccine clinical study;
  • Underwent major surgery within 3 months prior to the screening visit, or plan to undergo major surgery during the study period;
  • Diagnosis of active tuberculosis (TB) within 6 months prior to the screening visit;
  • Malignancy or history of malignancy;
  • Pregnant or breastfeeding women;
  • The investigator judges that there are conditions affecting the safety and efficacy evaluation of the study drug, as well as any other conditions that may lead to the participant's non-compliance with the study procedures and diary completion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tongren Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07688772 · SHR-1819-306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗