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Tests treatment safety and results for Seasonal Allergic Rhinitis
Official title A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT07091357
What this study is testing
What is SHR-1819 Injection?
SHR-1819 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for seasonal allergic rhinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- At the screening visit, the investigator assesses that the subject had poor how well it works with intranasal glucocorticoids and/or other...
- The subject has an immunoglobulin E (IgE)-mediated hypersensitivity to at least one pollen allergen in the current season or the same period, which...
- Willing and able to complete the patient diary as required by the protocol during the study period.
You likely can't join if
- During screening or within 2 weeks prior to the screening visit, the subject has other active rhinitis excluding SAR, including but not limited to...
- During screening or within 2 weeks prior to the screening visit, there may be other nasal comorbidities or concurrent diseases/states that could...
- During screening, there is glaucoma, cataract, ocular simple herpes, other ocular infections such as infectious conjunctivitis, acute conjunctivitis...
- During the screening visit, people with perennial allergic rhinitis (PAR) allergic to pet hair are included; if the subject currently has no contact...
- people with severe asthma who are receiving treatment with inhaled glucocorticoids (ICS) at a daily high dose or equivalent of more than twice the...
- people who initiated ICS treatment for asthma within 4 weeks prior to the screening visit. If the subject has been treated with a stable dose of ICS...
See the full eligibility criteria
Who can join
- 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...
- At the screening visit, the investigator assesses that the subject had poor how well it works with intranasal glucocorticoids and/or other medications for allergic rhinitis (antihistamines, leukotriene receptor...
- 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...
- Willing and able to complete the patient diary as required by the protocol during the study period.
- Female people of childbearing potential and male people 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...
What rules you out
- During screening or within 2 weeks prior to the screening visit, the subject has other active rhinitis excluding SAR, including but not limited to infectious rhinitis, drug-induced rhinitis, vasomotor rhinitis...
- During screening or within 2 weeks prior to the screening visit, there may be other nasal comorbidities or concurrent diseases/states that could affect the judgment of how well it works (including but not limited to...
- During screening, there is glaucoma, cataract, ocular simple herpes, other ocular infections such as infectious conjunctivitis, acute conjunctivitis, acute keratitis (except for symptoms related to allergic rhinitis).
- During the screening visit, people with perennial allergic rhinitis (PAR) allergic to pet hair are included; if the subject currently has no contact with pet hair, they can be enrolled.
- people with severe asthma who are receiving treatment with inhaled glucocorticoids (ICS) at a daily high dose or equivalent of more than twice the standard dose.
- people who initiated ICS treatment for asthma within 4 weeks prior to the screening visit. If the subject has been treated with a stable dose of ICS for at least 4 weeks before the screening visit, and the ICS dosage...
- Within 3 months prior to the screening visit, the subject had an acute exacerbation of asthma requiring hospitalization for more than 24 hours.
- Within 6 months prior to the screening visit, the subject has a history of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC).
- Within 1 week prior to randomization, the subject has received treatment with the following medications: leukotriene receptor antagonists. If the subject has been stably using mast cell membrane stabilizers...
- Within 2 weeks prior to the screening visit, the subject has used monoamine oxidase inhibitors.
- Within 4 weeks prior to the screening visit, the subject has received the following treatments: systemic glucocorticoids, systemic immunosuppressants (including but not limited to hydroxychloroquine, cyclosporine...
- Within 4 weeks prior to the screening visit, the subject initiated immunotherapy or plans to receive immunotherapy during the study. If the subject has maintained a stable dose of immunotherapy for 4 weeks before...
- Within 8 weeks prior to the screening visit or within 5 half-lives (if the half-life is known) of receiving investigational drugs or medical devices, whichever is longer. If the subject participated in a clinical study...
- Within 3 months prior to the screening visit, the subject has received or been exposed to other live vaccines or live attenuated vaccines, or participated in a vaccine clinical trial.
- Within 6 months prior to the screening visit, the subject has used other biological agents.
- Within 1 week prior to the screening visit, the subject requires systemic antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections).
- At the time of screening and within 2 weeks prior to screening, positive results for human immunodeficiency virus antibody (HIV), syphilis antibody, and hepatitis C virus (HCV) antibody; hepatitis B virus (HBV)...
- Within 3 months prior to the screening visit, the subject has undergone major surgery, or plans to undergo major surgery during the study period.
- Within 6 months prior to the screening visit, the subject was diagnosed with active tuberculosis.
- Within 6 months prior to the screening visit, the subject was diagnosed with or the investigator determined the presence of suspected immunosuppressive diseases.
- Within 1 year prior to the screening visit, the subject has a history of recurrent herpes zoster or Kaposi varicelliform eruption (≥2 times), disseminated herpes zoster, or disseminated herpes simplex.
- Has or has a history of malignant tumor (except for cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical in situ carcinoma that has been completely resected and shows no evidence of recurrence).
- Accompanied by other severe or chronic diseases that are poorly controlled.
- Pregnant or lactating women.
- Within 6 months prior to screening, the subject has a history of alcohol abuse.
- The investigator determines that there are conditions affecting the safety and how well it works evaluation of the study drug, as well as any other circumstances that may lead to the patient's non-compliance with the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.