ClinicalTrials.gg
RecruitingNCT06028490Updated Sep 11, 2023

A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.

A Phase 2 interventional study of GR1802 injection-1 and GR1802 injection-2 in Allergic Rhinitis, sponsored by Zheng Liu ENT. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Zheng Liu ENT · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

02

Conditions studied

  • Allergic Rhinitis

Browse trials for

03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 90 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Zheng Liu ENT is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

  1. Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and: standard treatment regimen for SAR was ineffective or subjective symptom control was unsatisfactory in the subject; positive test for at least one allergen associated with the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline TNSS of ≥ 6 points.
  2. Consent to highly effective

Key Exclusion Criteria:

  1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening;
  2. It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period.
  3. Patients with asthma requiring stable use of inhaled controlled medications;
  4. Previous or current malignant tumor within 5 years prior to screening;
  5. Presence of other acute or chronic diseases or abnormal laboratory tests at the time of screening that, in the investigator's assessment, may have a more serious impact on the efficacy or safety assessment of the subject;
  6. Live/ within 3 months prior to baseline;
  7. Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine;
  8. Unwillingness or inability to comply with the permitted and prohibited medication/treatment specifications of the study, inability to meet the pre-randomization drug elution cycle specified in the protocol;
  9. Women who are pregnant or breastfeeding;
  10. History of alcohol or drug abuse within 3 months prior to screening.
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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Interleukin-4 receptor responders 1

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

    Biological: GR1802 injection-1

  • Experimental
    Interleukin-4 receptor responders 2

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

    Biological: GR1802 injection-2

  • Placebo comparator
    Placebo

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

    Biological: Placebo

Interventions

  • BiologicalGR1802 injection-1

    subcutaneous,dose\*1

    Also known as: Xeligekimab

  • BiologicalGR1802 injection-2

    subcutaneous,dose\*2

    Also known as: Xeligekimab

  • BiologicalPlacebo

    subcutaneous,dose\*2

06

What researchers measure

Primary outcomes

  1. Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.

    The Total Nasal Symptom Score (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.

    Time frame: week 4

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06028490
Lead sponsor
Zheng Liu ENT
Responsible party
Zheng Liu ENT (Head of Otolaryngology, Principal Investigator, Clinical Professor, Tongji Hospital) — Sponsor-investigator
First posted
Sep 8, 2023
Start date
Sep 7, 2023
Primary completion
Nov 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Sep 11, 2023

Study contacts

Zheng Liu, PHD
Contact
zhengliuent@hotmail.com
027-83665555
Rong fei Zhu, PHD
Contact
zrf13092@163.com
027-83665555

Oversight

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

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