ClinicalTrials.gg
Not yet recruitingNCT07199257Updated Sep 30, 2025

A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis.

A Phase 3 interventional study of GR1802 injection and Placebo in Allergic Rhinitis, Seasonal, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. (part of Chongqing Genrix Biopharmaceutical Co., Ltd) · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
12 Years to 18 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.

Planned enrollment
16th of 27
144 · median 160
Started
2025
with 8 others
Phase 3
10 of 27
5 open now
Primary completion
2027-05
later than 12 of 13 live
Registered
20th of 27
by date
Lead sponsor
2 of 27
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Among the 27 studies in Rhinitis, Allergic, Seasonal with a site in China, this one is the 16th largest by planned enrollment, is one of 9 that started in 2025, is one of 10 in phase 3, reaches primary completion later than 12 of the 13 other live ones, and was the 20th 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:

6 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: 12 Years to 18 Years · all sexes · no healthy volunteers.

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02

Study summary

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies.

03

Conditions studied

  • Allergic Rhinitis, Seasonal
04

Who can participate

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

Eligibility criteria

Main Inclusion Criteria:

  1. Voluntarily sign the form.
  2. Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
  3. Poor control of seasonal allergic rhinitis with nasal or other therapeutic agents during the same pollen season in the past.
  4. Weight≥30kg.
  5. Symptom severity scores for the season met the enrollment criteria.

Main Exclusion Criteria:

  1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
  2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
  3. Subjects with poorly controlled recent asthma conditions.
  4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
  5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
  6. Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.
Terms in these criteria, in plain language(2)

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.

05

Study design

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

Study arms

  • Experimental
    Interleukin-4 receptor responder(Part One)

    Part one

    Biological: GR1802 injection

  • Experimental
    Interleukin-4 receptor responder(Part Two)

    Part two

    Biological: GR1802 injection

  • Placebo comparator
    Placebo

    Part two

    Biological: Placebo

Interventions

  • Recombinant fully human anti-IL4Rα monoclonal antibody drug.

  • BiologicalPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)(Part One)

    Time frame: up to 12 weeks

  2. Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two)

    Scores range from 0 to 12, with higher scores indicating more severe symptoms.

    Time frame: up to 2 weeks

Secondary outcomes

  1. Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two)

    Scores range from 0 to 9, with higher scores indicating more severe symptoms.

    Time frame: up to 2、4 weeks

  2. Percentage Change from Baseline in rTNSS(Part One/Two)

    Scores range from 0 to 12, with higher scores indicating more severe symptoms.

    Time frame: up to 2、4 weeks

  3. Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two)

    Scores range from 0 to 12, with higher scores indicating more severe symptoms.

    Time frame: week 2、4

  4. Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two)

    Scores range from 0 to 9, with higher scores indicating more severe symptoms.

    Time frame: week 2、4

  5. Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two)

    There are 28 questions in 7 fields,Each question is answered on a 7-point scale (0 to 6).

    Time frame: week2、4

  6. Incidence of ADAs(Part One/Two)

    Time frame: up to 12 weeks

  7. drug concentration、Ctrough(Part One/Two)

    Time frame: up to 12 weeks

07

Study locations

1 site
08

Timeline

Tracking 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

Start is estimated for Sep 2025; primary completion for May 2027, 19 months later.

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 19 months is above 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
Sep 22, 2025
First posted
Sep 30, 2025
StartEst.
Sep 25, 2025
Primary completionEst.
May 15, 2027
CompletionEst.
Jul 31, 2027
Last update
Sep 30, 2025
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.
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07199257
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Sep 25, 2025 (estimated)
Primary completion
May 15, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 30, 2025

Study contacts

liaison officer
Contact
fangxiaoyan@genrixbio.com
021-50805988-8039

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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