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

Primary Purpose

Allergic Rhinitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GR1802 injection-1
GR1802 injection-2
Placebo
Sponsored by
Zheng Liu ENT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: 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. Consent to highly effective contraception Key Exclusion Criteria: Other nasal comorbidities or co-morbidities/states that may be present at the time of screening; It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period. Patients with asthma requiring stable use of inhaled controlled medications; Previous or current malignant tumor within 5 years prior to screening; 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; Live/live attenuated vaccine within 3 months prior to baseline; Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine; 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; Women who are pregnant or breastfeeding; History of alcohol or drug abuse within 3 months prior to screening.

Sites / Locations

  • Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Interleukin-4 receptor responders 1

Interleukin-4 receptor responders 2

Placebo

Arm Description

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
September 7, 2023
Sponsor
Zheng Liu ENT
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1. Study Identification

Unique Protocol Identification Number
NCT06028490
Brief Title
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zheng Liu ENT

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interleukin-4 receptor responders 1
Arm Type
Experimental
Arm Description
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Arm Title
Interleukin-4 receptor responders 2
Arm Type
Experimental
Arm Description
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Intervention Type
Biological
Intervention Name(s)
GR1802 injection-1
Other Intervention Name(s)
Xeligekimab
Intervention Description
subcutaneous,dose*1
Intervention Type
Biological
Intervention Name(s)
GR1802 injection-2
Other Intervention Name(s)
Xeligekimab
Intervention Description
subcutaneous,dose*2
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
subcutaneous,dose*2
Primary Outcome Measure Information:
Title
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Consent to highly effective contraception Key Exclusion Criteria: Other nasal comorbidities or co-morbidities/states that may be present at the time of screening; It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period. Patients with asthma requiring stable use of inhaled controlled medications; Previous or current malignant tumor within 5 years prior to screening; 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; Live/live attenuated vaccine within 3 months prior to baseline; Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine; 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; Women who are pregnant or breastfeeding; History of alcohol or drug abuse within 3 months prior to screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Liu, PHD
Phone
027-83665555
Email
zhengliuent@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rong fei Zhu, PHD
Phone
027-83665555
Email
zrf13092@163.com
Facility Information:
Facility Name
Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongfei Zhu
Phone
18986292602
Email
zrf13092@163.com
First Name & Middle Initial & Last Name & Degree
Zheng liu
Phone
18607110505
Email
zhengliuent@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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