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Clinical trial

The Efficacy and Safety of Humanized Antibody Targeting the Interleukin-4 Receptor Alpha Subunit (IL-4Rα) in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Standard Treatment： A Randomized, Double-Blind, Placebo-controlled IIT Study

ID
Name
CM310_IIS_SAR07
Description
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 arms
Trial start
2024-05-30
Estimated PCD
2025-05-30
Trial end
2025-05-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Interleukin-4 receptor responders
Interleukin-4 receptor was injected subcutaneously.
Arms:
Interleukin-4 receptor responders
Placebo
Placebo was injected subcutaneously.
Arms:
Placebo
Size
80
Primary endpoint
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2.
up to Week 2
Eligibility criteria
Inclusion Criteria: * Voluntarily sign the informed consent form. Exclusion Criteria: * Have any condition that are not suitable for participating in this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-03-08

1 organization

1 product

1 indication

Organization
Beijing Tongren Hospital
Product
Interleukin-4 receptor
Indication
Allergic Rhinitis