Status:
UNKNOWN
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
Lead Sponsor:
Zheng Liu ENT
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06028490
Start Date
September 7 2023
End Date
November 1 2023
Last Update
September 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030