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610 (anti-IL-5 antibody) in severe eosinophilic asthma
NCT06680947Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2024
- Primary completion
- Feb 2027
- Countries
- 1
- Sponsor
- 3S Guojian Pharmaceutical
- Modality
- Small Molecules, Monoclonal Antibodies
- Drugs
- 610
- Conditions
- asthma
01
Overview
Phase 2, randomised, double-blind trial of 610 in asthma (3 arms), sponsored by 3S Guojian Pharmaceutical. Primary endpoint: Pre-bronchodilator Forced Expiratory Volume in One Second at 52 weeks. Started Dec 2024; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Group A
610 subcutaneous injection for 52 weeks
Group B
610 subcutaneous injection for 52 weeks
Placebo group
Placebo subcutaneous injection for 52 weeks
03
Who it enrols
Adults aged 18-75 with physician-diagnosed asthma for ≥12 months requiring ICS and at least one other control medication for ≥6 months, with ≥1 moderate exacerbation in past 12 months and ACQ score ≥1.5. Excludes patients with other lung conditions, recent severe exacerbations, other eosinophilic diseases, significant cardiovascular disease, active hepatitis B/C or HIV, or monoclonal antibody allergy.
04
Endpoints
Primary
Pre-bronchodilator Forced Expiratory Volume in One Second
Secondary
Pre-bronchodilator Forced Expiratory Volume in One Second
Number of Asthma Exacerbations
Number of Asthma Exacerbations Requiring Hospitalization or Emergency Room Visits
Asthma Control Questionnaire
St. George's Respiratory Questionnaire
Adverse Events
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