ClinicalTrials.gg
Active, not recruitingNCT07688772Updated Oct 22, 2026

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

A Phase 3 interventional study of SHR-1819 Injection and SHR-1819 Injection Placebo in Seasonal Allergic Rhinitis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment

Updated Oct 22, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓

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Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 27 studies in Rhinitis, Allergic, Seasonal with a site in China — 12 open to participants now, 14 under way, 8 of them phase 3. Rhinitis, Allergic, Seasonal · China.

Enrollment
9th of 27
220 · median 160
Started
2026
with 5 others
Phase 3
10 of 27
5 open now
Primary completion
2026-12
later than 10 of 13 live
Registered
26th of 27
by date
Lead sponsor
2 of 27
Guangdong Hengrui Pharmaceutical Co., Ltd

Among the 27 studies in Rhinitis, Allergic, Seasonal with a site in China, this one is the 9th largest by enrollment, is one of 6 that started in 2026, is one of 10 in phase 3, reaches primary completion later than 10 of the 13 other live ones, and was the 26th registered.

Rhinitis, Allergic, Seasonal

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

Browse Rhinitis, Allergic, Seasonal studies →

Open to participants now

12 of the 27 studies in Rhinitis, Allergic, Seasonal with a site in China are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 17 Rhinitis, Allergic, Seasonal studies recruiting now, 2 (12%) set no upper age limit and 15 (88%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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).

03

Conditions studied

  • Seasonal Allergic Rhinitis
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 75 years (inclusive) at the time of signing the Form, of any sex;
  2. 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;
  3. The investigator assesses that the participant has had a poor response to intranasal and/or other medications for allergic rhinitis (antihistamines, leukotriene receptor antagonists, etc.) during the same pollen season in previous years;
  4. Participants exhibit an immunoglobulin E-mediated reaction to at least one seasonal pollen allergen;
  5. 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;
  6. Female participants of and male participants whose partners are women of childbearing potential must agree to use the measures specified in the protocol from the signing of the ICF until 3 months after the last dose.

Exclusion criteria

Exclusion Criteria:

  1. At screening or within 2 weeks prior to the screening visit, the participant has other active rhinitis besides SAR;
  2. 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;
  3. Has glaucoma, cataract, ocular herpes simplex, other ocular infections such as infectious conjunctivitis, acute conjunctivitis, or acute keratitis at screening;
  4. History of Vernal Keratoconjunctivitis (VKC) and/or Atopic Keratoconjunctivitis (AKC) within 6 months prior to the screening visit;
  5. Use of Monoamine Oxidase Inhibitors within 2 weeks prior to the screening visit;
  6. Initiation of immunotherapy within 4 weeks prior to the screening visit or planned receipt of immunotherapy during the study period;
  7. Receipt of an 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 Form (ICF), which can demonstrate screening failure and no drug administration, may be included;
  8. Vaccination with or exposure to other live or within 3 months prior to the screening visit, or participation in a vaccine clinical study;
  9. Underwent major surgery within 3 months prior to the screening visit, or plan to undergo major surgery during the study period;
  10. Diagnosis of active tuberculosis (TB) within 6 months prior to the screening visit;
  11. or history of malignancy;
  12. Pregnant or breastfeeding women;
  13. 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    SHR-1819 Group

    SHR-1819 injection.

    Drug: SHR-1819 Injection

  • Placebo comparator
    SHR-1819 Placebo Group

    SHR-1819 injection placebo.

    Drug: SHR-1819 Injection Placebo

Interventions

  • SHR-1819 injection.

  • DrugSHR-1819 Injection Placebo

    SHR-1819 injection placebo.

06

What researchers measure

Primary outcomes

  1. Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 2 weeks of treatment.

    Time frame: 2 weeks.

Secondary outcomes

  1. Mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) within 4 weeks of treatment.

    Time frame: 4 weeks.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.

Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, Seasonal, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's planned 4 months is close to that.

Counting every sponsor, half of 37 studies reached it within 4 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Jul 7, 2026
StartActual
Aug 11, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 22, 2026
Enrollment
196 (estimated)→220 (actual)
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Recruiting→Active, not recruiting
    Enrollment 196 (estimated)→220 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07688772
Responsible party
Sponsor
First posted
Jul 7, 2026
Start date
Aug 11, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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