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Allergic RhinitisPhase 2NCT06315426

A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).

A Phase 2 study testing GR1802 injection in people with Allergic Rhinitis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 15 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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
240 participants
Where
15 sitesChina
Study dates
24 Mar 2024to Oct 2025
Phase
Phase 2
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:

  1. Voluntarily sign the informed consent form.
  2. Seasonal allergic rhinitis has been prevalent for at least 2 years.
  3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
  4. Positive SPT or serum-specific IgE test results.
  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

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • Chengdu Second People's Hospital

    Chengdu, Sichuan, 610000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Shandong Second Provincial General Hospital

    Jinan, Shandong, 250000

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434000

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430000

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430000

  • Xi'an Daxing Hospital

    Xi’an, Shanxi, 710000

  • Central Hospital of Qinghe County

    Xingtai, Hebei, 054800

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II 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. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

Being tested
GR1802 injection, Placebo
Medical subject headings
Rhinitis, Allergic

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 NCT06315426
Study groupRoleWhat they receive
Interleukin-4 receptor responder 1ExperimentalNot described
Receives: Biological: GR1802 injection
Interleukin-4 receptor responder 2ExperimentalNot described
Receives: Biological: GR1802 injection
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

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

  1. Change from Baseline in rTNSS( reflective total nasal symptom scores)

    TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.

    Measured: Over 2 weeks

Secondary outcomes (8)

  1. Change from Baseline in rTOSS( reflective total ocular symptom scores)

    TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms.

    Measured: Over 2、4 weeks

  2. Change from Baseline in rTNSS

    TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.

    Measured: Over 4 weeks

  3. Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)

    TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.

    Measured: week 2、4

  4. Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)

    TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms.

    Measured: week 2、4

  5. Change from baseline in VAS(Visual Analog Scale) score

    Patients marked the score corresponding to the severity of the current overall AR symptoms by drawing a line on a 0-10 cm scale，the higher the score, the worse the symptoms.

    Measured: week2、4

  6. Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores

    The RQLQ is used to measure the problems that adults with rhinoconjunctivitis experience in their daily lives. It has 28 questions in 7 domains. The total score is the sum of the 7 domain scores, with higher scores being associated with poorer quality of life.

    Measured: week2、4

  7. Adverse events (AEs)

    Incidence of AEs.

    Measured: up to 12 weeks

  8. Immunogenicity characteristics

    Positive rate of ADA(anti-drug antibody) testing

    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 posted18 Mar 2024
  2. Study start24 Mar 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionOct 2025 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06315426
Sponsor's protocol ID
GR1802-011
Status last verified
Apr 2025
First submitted
11 Mar 2024
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GR1802 injection in people with Allergic Rhinitis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 15 sites 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: under way, not looking for participants, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change from Baseline in rTNSS( reflective total nasal symptom scores) (time frame: Over 2 weeks). 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 NCT06315426.

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 25 Apr 2025.

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