Clincosm LogoSign in Get a demo

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

Sponsor
Zheng Liu ENT (Other)
Overall Status
Recruiting
CT.gov ID
NCT06028490
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
1.8
Anticipated Duration (Months)
49.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: GR1802 injection-1
  • Biological: GR1802 injection-2
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial.
Actual Study Start Date :
Sep 7, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interleukin-4 receptor responders 1

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Biological: GR1802 injection-1
subcutaneous，dose*1
Other Names:
  • Xeligekimab

    		•
    Experimental: Interleukin-4 receptor responders 2

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

    Biological: GR1802 injection-2
    subcutaneous，dose*2
    Other Names:
  • Xeligekimab

    		•
    Placebo Comparator: Placebo

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

    Biological: Placebo
    subcutaneous，dose*2

    Outcome Measures

    Primary Outcome Measures

    1. Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. [week 4]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 contraception

    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/live attenuated vaccine 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Zheng Liu ENT

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zheng Liu ENT, Head of Otolaryngology, Principal Investigator, Clinical Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT06028490
    Other Study ID Numbers:
    • 2081-IIT-SAR
    First Posted:
    Sep 8, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Rhinitis, Allergic, Seasonal

    Study Results

    No Results Posted as of Sep 11, 2023