NCT07646587RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 2 Jun 2026
- Start date
- Jun 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Windward Bio
- Diseases
- COPD
- NCT number
- NCT07646587
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 105
- From Jun 2026 to the primary completion date, Dec 2027
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period
Other illness
- 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
Other
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.