Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06300203

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

Led by Beijing Tongren Hospital · Updated on 2025-09-25

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Seasonal allergic rhinitis (AR) is a common chronic nasal condition caused by an overreaction to allergens such as pollen, leading to symptoms like sneezing, a runny nose, itching, and nasal congestion. This condition often affects quality of life by causing fatigue and difficulty concentrating, and it may be linked with asthma in many patients. The study aims to evaluate a humanized antibody targeting the interleukin-4 receptor alpha subunit in people with uncontrolled seasonal allergic rhinitis who are already receiving standard treatment. Participants in this randomized, double-blind, placebo-controlled Phase 2 study will receive either a subcutaneous injection of the interleukin-4 receptor antibody or a placebo injection. The study will compare these treatments in their effect on symptoms of seasonal allergic rhinitis. The treatment period lasts up to 2 weeks, with ongoing monitoring to assess changes in nasal symptoms. Throughout the study, participants will report their nasal symptoms daily, focusing on changes from their baseline condition. Researchers will measure the average change in total nasal symptom scores by week 2 to evaluate the treatment's effects. The study includes safety monitoring and requires participants to provide informed consent. Total participant involvement spans the treatment and observation periods, ensuring thorough assessment of efficacy and safety.

CONDITIONS

Brief Title

Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent form
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 weeks

Participants receive subcutaneous injections of either the interleukin-4 receptor antibody or placebo while continuing their standard treatment for seasonal allergic rhinitis.

Weekly visits for up to 2 weeks

Trial Site Locations

Total: 1 location

1

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

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Research Team

L

Luo Zhang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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