RecruitingPhase 3

Efficacy and Safety Study of 610 in Patients With Severe Asthma

China480 participantsStarted 2024-06-24

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Annualized rate of severe exacerbation events

Timeframe: Up to 52 weeks

NCT IDNCT06323213

SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

Qinghong Zhou, MD