Recruiting
Efficacy and Safety Study of 610 in Patients With Severe Asthma
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
ClinicalTrials.gov IDNCT06323213
PhasePHASE3
Enrollment480
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Age18 Years
SexALL
Conditions studied
Asthma
About this study
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Interventions
- Drug: 610 — 610 subcutaneously injection.
- Drug: Placebo — Placebo subcutaneously injection.
Primary outcomes
- Annualized rate of severe exacerbation events (Up to 52 weeks)
Eligibility information
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.
Study locations
- Shanghai General Hospital, Shanghai, Shanghai Municipality China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.