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New treatment option for COPD (Chronic Obstructive Pulmonary Disease)
Official title A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
ClinicalTrials.gov ID: NCT07646587
What this study is testing
What is WIN378?
WIN378 is an investigational medicine, being studied as a potential treatment for copd (chronic obstructive pulmonary disease).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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 ≥ 3 months
- Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months
- Elevated eosinophil count
You likely can't join if
- 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...
- 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
See the full eligibility 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 ≥ 3 months
- Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months
- Elevated eosinophil count
- Weight/BMI within allowed range
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami Lakes, Florida, United States
- North Dartmouth, Massachusetts, United States
- Charlotte, North Carolina, United States
- McKinney, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Lakes, Florida, United States; North Dartmouth, Massachusetts, United States; Charlotte, North Carolina, United States; McKinney, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.