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Clinical Trials in China / NCT06323213
Recruiting Phase 3

Efficacy and Safety Study of 610 in Patients With Severe Asthma

NCT06323213 · tracked via the Priya Life Science China tracker
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Phase
Phase 3
Started
2024-06-24
Last updated
2026-01-07

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

610Placebo

610: 610 subcutaneously injection.

Placebo: Placebo subcutaneously injection.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Able to give written informed consent prior to participation in the study. 2. Male or female adults ages 18 to 75 years old when signing the informed consent. 3. Documented diagnosis of asthma for at least one year prior to screening. 4. 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 Criteria: 1. Presence of a known pre-existing, clinically important lung condition other than asthma. 2. Severe asthma exacerbation within 4 weeks prior to randomization. 3. Subjects with any eosinophilic diseases other than asthma. 4. Known, pre-existing severe or clinically significant cardiovascular disease. 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment. 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 7. Subjects with allergy/intolerance to a monoclonal antibody.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai General Hospital Shanghai Shanghai Municipality Recruiting

More Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06323213 on ClinicalTrials.gov ↗ ← All trials in China