Efficacy and Safety Study of 610 in Patients With Severe Asthma

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT06323213

Run by

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

People needed

480

Starts

2024-06-24

Expected to finish

2027-09-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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