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
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
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)
- Annualized rate of severe exacerbation events — Up to 52 weeks
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | Recruiting |
More Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. trials in China
Other trials for the same condition
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Active, not recruiting
Childhood Infection and Immunity Longitudinal Cohort
Starting soon
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