WIN378 for moderate to severe chronic obstructive pulmonary disease
Tests different doses of WIN378 in adults with moderate to severe COPD.
Plain-language title generated from the registry record
Registry title: A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
Key facts
- Where
- Charlotte, DuBois, Jacksonville, Los Angeles, McKinney, Medford, Miami Lakes, North Dartmouth, and Waxahachie, United StatesSee the 9 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07646587, who can take part
Where in United States
- CharlotteCharlotte, United StatesTaking people
- DuBoisDuBois, United StatesTaking people
- JacksonvilleJacksonville, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- McKinneyMcKinney, United StatesTaking people
- MedfordMedford, United StatesTaking people
- Miami LakesMiami Lakes, United StatesTaking people
- North DartmouthNorth Dartmouth, United StatesTaking people
- WaxahachieWaxahachie, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Windward Bio
- Trial code
- NCT07646587
- Record updated
- 23 October 2026
- Original description
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)Read full original descriptionShow less
A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease
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)
Inclusion: 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.
Exclusion: Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period; 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; Smoking or diagnosed substance use disorder; Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity; Pregnancy or breastfeeding.