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A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)

RecruitingPhase 2Ages 40 Years - 80 YearsAllWindward Bio
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In plain words

What the trial is, and whether it could suit you

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults aged 40 to 80 years * Post-BD spirometry at screening FEV1/FVC \< 0.70 and FEV1 30-80% predicted * On stable triple inhaled therapy (ICS/LABA/LAMA) for โ‰ฅ 3 months * Former smoker (โ‰ฅ 10 pack-year history) and abstinence from smoking for โ‰ฅ 6 months * Elevated eosinophil count * Weight/BMI within allowed range Exclusion Criteria: * Clinically significant pulmonary disease other than chronic obstructive pulmonary disease (COPD) * Clinically significant comorbid medical conditions or infections that, in the investigator's judgment, could affect participant safety or interfere with study conduct * Clinically significant cardiovascular disease * Recent respiratory infection or COPD exacerbation * Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period * Pregnancy or breastfeeding * Smoking or diagnosed substance use disorder * Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity
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What it tests

  • WIN378
  • Placebo
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Where

32 sites
WB Contracted Clinical Research Site
Los Angeles, United States
WB Contracted Clinical Research Site
Jacksonville, United States
WB Contracted Clinical Research Site
Miami Lakes, United States
WB Contracted Clinical Research Site
North Dartmouth, United States
WB Contracted Clinical Research Site
Charlotte, United States
WB Contracted Clinical Research Site
Medford, United States
WB Contracted Clinical Research Site
DuBois, United States
WB Contracted Clinical Research Site
McKinney, United States

โ€ฆand 24 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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