Shanghai General Hospital
Shanghai, Shanghai Municipality, China
NCT Number: NCT06680947
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
This study is active but is not currently recruiting participants.
18 year–75 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, China
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 36 weeks and follow-up period of 8 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneously injection.
Subcutaneously injection.
Time frame: Baseline (Day 1) and at week 52
FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.
Time frame: 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.
Time frame: Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52
Percentage of FEV1 will be measured using spirometry.
Time frame: From baseline (Day 1) to week 52
Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period
Time frame: From baseline (Day 1) to week 52
Asthma exacerbations that are associated with a hospitalization or an emergency room visit.
Time frame: From baseline (Day 1) to week 52
The ACQ contains five symptom questions (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze), one bronchodilator question and pre-bronchodilator FEV1 level. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ score is the average of the responses. Higher score indicates more limitations.
Time frame: From baseline (Day 1) to week 52
The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.
Time frame: Up to week 60
Number of participants with adverse events (AEs)
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Industry
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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