A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
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.
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedStudy Start
First participant enrolled
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedSeptember 11, 2023
September 1, 2023
2 months
August 31, 2023
September 7, 2023
Conditions
Outcome Measures
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.
week 4
Study Arms (3)
Interleukin-4 receptor responders 1
EXPERIMENTALRecombinant fully human anti-IL4Rα monoclonal antibody drug.
Interleukin-4 receptor responders 2
EXPERIMENTALRecombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo
PLACEBO COMPARATORRecombinant fully human anti-IL4Rα monoclonal antibody drug.
Interventions
subcutaneous，dose\*1
subcutaneous，dose\*2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zheng Liu ENTlead
Study Sites (1)
Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Otolaryngology, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 8, 2023
Study Start
September 7, 2023
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
September 11, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share