Seasonal Allergic RhinitisPhase 2NCT07091357
A Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
A Phase 2 study testing SHR-1819 Injection in people with Seasonal Allergic Rhinitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- SHR-1819 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
Who cannot join
- 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, non-allergic rhinitis with eosinophilia syndrome, dry rhinitis, atrophic rhinitis, etc.
- 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 efficacy (including but not limited to nasal polyps, cerebrospinal fluid rhinorrhea, severe nasal septal deviation, status after nasal or sinus surgery within 1 year, etc.), acute/chronic sinusitis (except those deemed non-influential by the investigator), or upper respiratory tract infections.
- 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, subjects 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.
- Subjects 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.
- Subjects 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 does not exceed twice the daily high dose, and the investigator assesses that the asthma remains well-controlled during the study while maintaining this dosage, such subjects may be screened.
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- 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, decongestants, nasal anticholinergic drugs, or other nasal preparations that may affect SAR assessment for ≥1 week at the time of screening, they may be included.
- 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, azathioprine, methotrexate, cyclophosphamide, tacrolimus, etc.), systemic traditional Chinese medicines (including proprietary Chinese medicines) for treating allergic rhinitis, and tricyclic antidepressants.
- 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 screening and can continue this dose throughout the study, they may be enrolled.
- 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 but only signed the informed consent form, and it can be proven that screening failed and no medication was administered, they may be enrolled.
- 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) infection meets the following (test results within 2 weeks prior to screening are acceptable).
- 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 efficacy evaluation of the study drug, as well as any other circumstances that may lead to the patient's non-compliance with the trial procedures and log filling.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
About this study
Official title: 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
This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- SHR-1819 Injection, SHR-1819 Injection Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1819 InjectionDrug
SHR-1819 injection.
SHR-1819 Injection PlaceboDrug
SHR-1819 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 Injection Dose 1 Group | Experimental | Not described Receives: Drug: SHR-1819 Injection |
| SHR-1819 Injection Dose 2 Group | Experimental | Not described Receives: Drug: SHR-1819 Injection |
| SHR-1819 Injection Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-1819 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change from baseline in daily retrospective total nasal symptom score (rTNSS).
Measured: Within 2 weeks of treatment.
Secondary outcomes (4)
The mean change from baseline in daily retrospective total nasal symptom score (rTNSS).
Measured: Within 4 weeks of treatment.
The mean change rate from baseline in daily retrospective total nasal symptom score (rTNSS).
Measured: Within 2 weeks of treatment.
The mean change rate from baseline in daily retrospective total nasal symptom score (rTNSS).
Measured: Within 4 weeks of treatment.
Adverse events (AEs).
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start6 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091357
- Sponsor's protocol ID
- SHR-1819-206
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07091357
- Acronym / sponsor ID
- SHR-1819-206
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial to evaluate the safety and efficacy of SHR-1819 injection in the treatment of patients with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 Injection Dose 1 Group | Experimental | Drug: SHR-1819 Injection |
| SHR-1819 Injection Dose 2 Group | Experimental | Drug: SHR-1819 Injection |
| SHR-1819 Injection Placebo Group | Placebo comparator | Drug: SHR-1819 Injection Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (26 listed)
- 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, non-allergic rhinitis with eosinophilia syndrome, dry rhinitis, atrophic rhinitis, etc.
- 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 efficacy (including but not limited to nasal polyps, cerebrospinal fluid rhinorrhea, severe nasal septal deviation, status after nasal or sinus surgery within 1 year, etc.), acute/chronic sinusitis (except those deemed non-influential by the investigator), or upper respiratory tract infections.
- 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, subjects 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.
- Subjects 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1819 InjectionSHR-1819 injection. | Drug | SHR-1819 Injection Dose 1 Group, SHR-1819 Injection Dose 2 Group |
| SHR-1819 Injection PlaceboSHR-1819 injection placebo. | Drug | SHR-1819 Injection Placebo Group |
Primary outcome
The mean change from baseline in daily retrospective total nasal symptom score (rTNSS).
Time frame: Within 2 weeks of treatment.
4 secondary outcomes
The mean change from baseline in daily retrospective total nasal symptom score (rTNSS).
Time frame: Within 4 weeks of treatment.
The mean change rate from baseline in daily retrospective total nasal symptom score (rTNSS).
Time frame: Within 2 weeks of treatment.
The mean change rate from baseline in daily retrospective total nasal symptom score (rTNSS).
Time frame: Within 4 weeks of treatment.
Adverse events (AEs).
Time frame: 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1819 Injection in people with Seasonal Allergic Rhinitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change from baseline in daily retrospective total nasal symptom score (rTNSS). (time frame: Within 2 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.