A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
Recruiting
Phase 2Interventional Study
COPD (Chronic Obstructive Pulmonary Disease)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Windward Bio · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe COPD to test a new medication called WIN378. Participants will take the medicine and have their lung function and safety monitored.
Are You a Good Fit for This Trial?
Must be takingICSLABALAMA
You may be able to join if
I am between 40 and 80 years old.
I have moderate to severe COPD.
I have been on stable inhaled therapy for at least 3 months.
I used to smoke but have not smoked in the last 6 months.
I have a high eosinophil count.
My weight and BMI are within the allowed range.
You may not be able to join if
I have other serious lung diseases besides COPD.
I have significant heart disease.
I had a recent respiratory infection or COPD flare-up.
I have taken any COPD biologic therapies recently.
I am pregnant or breastfeeding.
I currently smoke or have a substance use disorder.
I have any condition that would make it unsafe for me to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 th…
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)
Trial Locations
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Status
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 c…
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
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