RecruitingPhase 2

A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)

United States105 participantsStarted 2026-06-02

Plain-language summary

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 participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Adverse Events (AEs)

Timeframe: Week 0 - Week 36

Number of participants with Serious Adverse Events (SAEs)

Timeframe: Week 0 - Week 36

Change from baseline in systolic blood pressure (mmHg)

Timeframe: Week 0 - Week 36

Change from baseline in diastolic blood pressure (mmHg)

Timeframe: Week 0 - Week 36

Change from baseline in pulse rate (beats/minute)

Timeframe: Week 0 - Week 36

Change from baseline in respiratory rate (breaths/minute)

Timeframe: Week 0 - Week 36

Change from baseline in oxygen saturation (%)

Timeframe: Week 0 - Week 36

Trial details

NCT IDNCT07646587

SponsorWindward Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-17

Contact for this trial

Juliana Hutchinson, MSc

+4161 551 75 75 clinical.trial.enquiry@windwardbio.com

View on ClinicalTrials.gov More COPD (Chronic Obstructive Pulmonary Disease) trials

Plain-language summary

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with Adverse Events (AEs)

Timeframe: Week 0 - Week 36

Number of participants with Serious Adverse Events (SAEs)

Timeframe: Week 0 - Week 36

Change from baseline in systolic blood pressure (mmHg)

Timeframe: Week 0 - Week 36

Change from baseline in diastolic blood pressure (mmHg)

Timeframe: Week 0 - Week 36

Change from baseline in pulse rate (beats/minute)

Timeframe: Week 0 - Week 36

Change from baseline in respiratory rate (breaths/minute)

Timeframe: Week 0 - Week 36

Change from baseline in oxygen saturation (%)

Timeframe: Week 0 - Week 36