Allergic Rhinitis, SeasonalPhase 3NCT07154342
A Study of IL4Rα Monoclonal Antibody 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.
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 18 to 75 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
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 31 Jul 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
Main Inclusion Criteria:
- Voluntarily sign the informed consent form.
- Seasonal allergic rhinitis has been prevalent for at least 2 years.
- Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
- Positive serum-specific IgE test results.
- Symptom severity scores for the season met the enrollment criteria.
Main Exclusion Criteria:
- Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
- Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
- Subjects with poorly controlled recent asthma conditions.
- Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
- Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
- 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.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan university
Wuhan, Hubei, 430000
project manager, 021-50805988-8039, dongjie@genrixbio.com
Zheng Liu, PHD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR
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.
- Conditions
- Allergic Rhinitis, Seasonal
- 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 group | Role | What they receive |
|---|---|---|
| Interleukin-4 receptor responder | Experimental | Not described Receives: Biological: GR1802 injection |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in rTNSS( reflective total nasal symptom scores)
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Measured: up to 2 weeks
Secondary outcomes (8)
Change from Baseline in rTOSS( reflective total ocular symptom scores)
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Measured: up to 2、4 weeks
Change from Baseline in rTNSS
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Measured: up to 4 weeks
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Measured: week 2、4
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)
Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Measured: week 2、4
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores
There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6).
Measured: week2、4
Adverse events (AEs)
Measured: up to 12 weeks
Incidence of ADAs
Measured: up to 12 weeks
Ctrough
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.
- First posted4 Sep 2025
- Study start15 Aug 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis, SeasonalStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154342
- Sponsor's protocol ID
- GR1802-014
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR
- ClinicalTrials.gov ID
- NCT07154342
- Acronym / sponsor ID
- GR1802-014
- Conditions
- Allergic Rhinitis, Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interleukin-4 receptor responder | Experimental | Biological: GR1802 injection |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| GR1802 injectionRecombinant fully human anti-IL4Rα monoclonal antibody drug. | Biological | Interleukin-4 receptor responder |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Change from Baseline in rTNSS( reflective total nasal symptom scores)
Time frame: up to 2 weeks
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
8 secondary outcomes
Change from Baseline in rTOSS( reflective total ocular symptom scores)
Time frame: up to 2、4 weeks
Change from Baseline in rTNSS
Time frame: up to 4 weeks
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)
Time frame: week 2、4
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)
Time frame: week 2、4
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores
Time frame: week2、4
Adverse events (AEs)
Time frame: up to 12 weeks
Incidence of ADAs
Time frame: up to 12 weeks
Ctrough
Time frame: up to 12 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 4 Sep 2025.
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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.
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 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: looking for participants now, as of the sponsor's last update on 4 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?
Change from Baseline in rTNSS( reflective total nasal symptom scores) (time frame: up to 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 4 Sep 2025.