Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

— MEGREZ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300203
• Other study ID #: CM310_IIS_SAR07
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 30, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Beijing Tongren Hospital
• Contact: Luo Zhang
• Phone: +86-13910830399
• Email: dr.luozhang[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.

AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset < 4 days/week, or < 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Voluntarily sign the informed consent form.

Exclusion Criteria:

• Have any condition that are not suitable for participating in this study.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Biological:
• Interleukin-4 receptor responders
Interleukin-4 receptor was injected subcutaneously.

Other:
• Placebo
Placebo was injected subcutaneously.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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