A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma
- Registration Number
- NCT06680947
- Brief Summary
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
- Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 20 weeks and follow-up period of 8 weeks.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 225
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- Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
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- Female and male aged 18 to 75 years.
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- Diagnosed with asthma for ≥12 months that meet GINA.
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- History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
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- Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
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- Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.
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- Presence of a known pre-existing, clinically important lung condition other than Asthma.
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- Severe asthma exacerbation within 4 weeks prior to randomization.
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- Subjects with any eosinophilic diseases other than asthma.
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- Known, pre-existing severe or clinically significant cardiovascular disease.
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- known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
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- Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
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- Subjects with allergy/intolerance to a monoclonal antibody.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A 610 Subjects will receive 610 for 36 weeks. Group B 610 Subjects will receive 610 for 36 weeks. Placebo group Placebo Subjects will receive placebo for 36 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 36 Baseline (Day 1) and at week 36 FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
- Secondary Outcome Measures
Name Time Method Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16 Baseline (Day 1) and at week 16 FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12, 16,20,28,36 Baseline (Day 1) and at week 4,8,12,16,20,28,36 Percentage of FEV1 will be measured using spirometry.
Number of asthma exacerbation through study week 36 From baseline (Day 1) to week 36 Annualized rate of severe exacerbation events during the 36-week placebo-controlled treatment period
Number of asthma exacerbations requiring hospitalization or emergency room visits From baseline (Day 1) to week 36 Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Change from baseline in ACQ score. From baseline (Day 1) to week 36 Change from baseline to week 36 in ACQ score
Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) From baseline (Day 1) to week 36 Change from baseline to week 36 in SGRQ score
Assessment of adverse events (AEs) Up to week 44 Number of participants with adverse events (AEs)