RecruitingPhase 3NCT06323213

Efficacy and Safety Study of 610 in Patients With Severe Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

480 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

Able to give written informed consent prior to participation in the study.
Male or female adults ages 18 to 75 years old when signing the informed consent.
Documented diagnosis of asthma for at least one year prior to screening.
History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Exclusion Criteria7

Presence of a known pre-existing, clinically important lung condition other than asthma.
Severe asthma exacerbation within 4 weeks prior to randomization.
Subjects with any eosinophilic diseases other than asthma.
Known, pre-existing severe or clinically significant cardiovascular disease.
known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
Subjects with allergy/intolerance to a monoclonal antibody.