A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
Recruiting · NCT07646587 · Interventional (participants receive a specific treatment) · Lead sponsor: Windward Bio
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboWIN378
What this trial is about
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)
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
21 locations listed across 7 US states.
- WB Contracted Clinical Research Site - Los Angeles, California, United States
- WB Contracted Clinical Research Site - Miami Lakes, Florida, United States
- WB Contracted Clinical Research Site - North Dartmouth, Massachusetts, United States
- WB Contracted Clinical Research Site - Charlotte, North Carolina, United States
- WB Contracted Clinical Research Site - Medford, Oregon, United States
- WB Contracted Clinical Research Site - DuBois, Pennsylvania, United States
- WB Contracted Clinical Research Site - McKinney, Texas, United States
- WB Contracted Clinical Research Site - Waxahachie, Texas, United States
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires, Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires, Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires, Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires, Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires, Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires, Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires F.D., Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Buenos Aires F.D., Argentina
- WB Contracted Clinical Research Site - Buenos Aires, Mendoza Province, Argentina
- WB Contracted Clinical Research Site - Mendoza, Mendoza Province, Argentina
- WB Contracted Clinical Research Site - Rosario, Santa Fe Province, Argentina
- WB Contracted Clinical Research Site - Rosario, Santa Fe Province, Argentina
- WB Contracted Clinical Research Site - Santa Fe, Santa Fe Province, Argentina