A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
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
Who can join
Ages 40 to 80 · All sexes
Full eligibility criteria
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 ≥ 3 months * Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 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
About the study
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)
What is being tested
- WIN378 (drug)
- Placebo (drug)
Sponsor: Windward Bio · Participants: 105 · Started: Jun 2, 2026
Contact the study team
- Juliana Hutchinson, MSc · Phone: +4161 551 75 75
Official record on ClinicalTrials.gov — NCT07646587
Locations in the U.S.
| California | WB Contracted Clinical Research Site, Los Angeles |
| Florida | WB Contracted Clinical Research Site, Miami Lakes |
| Massachusetts | WB Contracted Clinical Research Site, North Dartmouth |
| North Carolina | WB Contracted Clinical Research Site, Charlotte |
| Oregon | WB Contracted Clinical Research Site, Medford |
| Pennsylvania | WB Contracted Clinical Research Site, DuBois |
| Texas | WB Contracted Clinical Research Site, McKinney WB Contracted Clinical Research Site, Waxahachie |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.