Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
MEGREZ
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
1 other identifier
interventional
120
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 Mar 2024
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
March 2, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
March 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
September 25, 2025
August 1, 2025
2.3 years
March 2, 2024
September 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2.
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.
up to Week 2
Study Arms (2)
Interleukin-4 receptor responders
EXPERIMENTALInterleukin-4 receptor was injected subcutaneously.
Placebo
PLACEBO COMPARATORPlacebo was injected subcutaneously.
Interventions
Interleukin-4 receptor was injected subcutaneously.
Eligibility Criteria
You may qualify if:
- Voluntarily sign the informed consent form.
You may not qualify if:
- Have any condition that are not suitable for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luo Zhang
Beijing Tong-Ren hospital
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
Study Record Dates
First Submitted
March 2, 2024
First Posted
March 8, 2024
Study Start
March 18, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
September 25, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share