Efficacy and Safety Study of 610 in Patients With Severe Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 610, Placebo.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 610 in Chinese Adult Subjects With Severe Eosinophilic Asthma
Overview
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
Detailed description
The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.
Interventions
- Drug 610
610 subcutaneously injection. - Drug Placebo
Placebo subcutaneously injection.
Primary outcome measures
- Annualized rate of severe exacerbation events [Time frame: Up to 52 weeks]
Secondary outcome measures (6)
- Time to first severe exacerbation event [Time frame: Up to 52 weeks]
- Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit [Time frame: Up to 52 weeks]
- Change from baseline in ACQ score [Time frame: Up to 52 weeks]
- Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) [Time frame: Up to 52 weeks]
- Change in pre-bronchodilator forced expiratory volume (FEV1) [Time frame: Up to 52 weeks]
- Assessment of adverse events (AEs) [Time frame: Up to 60 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT06323213 · SSGJ-610-BA-III-01