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Allergic Rhinitis, SeasonalPhase 3NCT07199257

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

A Phase 3 study testing GR1802 injection in people with Allergic Rhinitis, Seasonal, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Allergic Rhinitis, Seasonal
What is being tested?
GR1802 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
1 siteChina
Study dates
25 Sep 2025to 31 Jul 2027
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Main Inclusion Criteria:

  1. Voluntarily sign the informed consent 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 glucocorticoids 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

liaison officer contact

021-50805988-8039

fangxiaoyan@genrixbio.com

China1 site

  • Zhongnan Hospital of Wuhan university

    Wuhan, Hubei, 430000

    project manager, 021-50805988-8039, dongjie@genrixbio.com

    Zheng Liu, PHD

Other trials in China

About this study

Official title: A Multicenter Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1802 Injection in Combination With Background Therapy in Patients With Seasonal Allergic Rhinitis.

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.

Being tested
GR1802 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.

  • GR1802 injectionBiological

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

  • PlaceboBiological

    Placebo

Study groups in NCT07199257
Study groupRoleWhat they receive
Interleukin-4 receptor responder(Part One)ExperimentalPart one
Receives: Biological: GR1802 injection
Interleukin-4 receptor responder(Part Two)ExperimentalPart two
Receives: Biological: GR1802 injection
PlaceboPlacebo comparatorPart two
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)(Part One)

    Measured: 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.

    Measured: up to 2 weeks

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: week2、4

  6. Incidence of ADAs(Part One/Two)

    Measured: up to 12 weeks

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

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start25 Sep 2025 (estimated)
  3. Primary completion15 May 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07199257
Sponsor's protocol ID
GR1802-015
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GR1802 injection in people with Allergic Rhinitis, Seasonal, run by Genrix (Shanghai) Biopharmaceutical 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?

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: opening soon, as of the sponsor's last update on 30 Sep 2025. 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?

Contact liaison officer (021-50805988-8039, fangxiaoyan@genrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs)(Part One) (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07199257.

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 30 Sep 2025.

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