Seasonal Allergic RhinitisPhase 3NCT07688772
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
A Phase 3 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 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). 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
- 220 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2026to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100005
About this study
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
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).
- 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 Group | Experimental | SHR-1819 injection. Receives: Drug: SHR-1819 Injection |
| SHR-1819 Placebo Group | Placebo comparator | SHR-1819 injection placebo. Receives: Drug: SHR-1819 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment.
Measured: 2 weeks.
Secondary outcomes (10)
Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 4 weeks of treatment.
Measured: 4 weeks.
Mean percent change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 and 4 weeks.
Mean change from baseline in the daily reflective Total Ocular Symptom Score (rTOSS) within 2 and 4 weeks of treatment.
Measured: 2 and 4 weeks.
Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score within 2 and 4 weeks of treatment.
Measured: 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.
Measured: 2 and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start11 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1819 compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 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
- NCT07688772
- Sponsor's protocol ID
- SHR-1819-306
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 22 Oct 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07688772
- Acronym / sponsor ID
- SHR-1819-306
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jul 2026 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1819 compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 Group | Experimental | Drug: SHR-1819 InjectionSHR-1819 injection. |
| SHR-1819 Placebo Group | Placebo comparator | Drug: SHR-1819 Injection PlaceboSHR-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)
- 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;
Key exclusion criteria (13 listed)
- 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;
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 Group |
| SHR-1819 Injection PlaceboSHR-1819 injection placebo. | Drug | SHR-1819 Placebo Group |
Primary outcome
Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment.
Time frame: 2 weeks.
10 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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 3 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 13 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment. (time frame: 2 weeks.). 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 22 Oct 2026.