Clinical trial NCT06028490: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
timeFrame: week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
state: Hubei
Study officials:
References: