NCT07646587 · Windward Bio
A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
(Sirius)
What this study 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.
View original scientific description
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.
Interventions
DRUG
WIN378
WIN378 is a fully human, long-acting monoclonal antibody that targets the ligand of thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving COPD control over an extended dosing interval
DRUG
Placebo
Placebo matching WIN378
Primary outcome measures
Number of participants with Adverse Events (AEs)
Time frame: Week 0 - Week 36
Number of participants with Serious Adverse Events (SAEs)
Time frame: Week 0 - Week 36
Change from baseline in systolic blood pressure (mmHg)
Time frame: Week 0 - Week 36
Change from baseline in diastolic blood pressure (mmHg)
Time frame: Week 0 - Week 36
Change from baseline in pulse rate (beats/minute)
Time frame: Week 0 - Week 36
Change from baseline in respiratory rate (breaths/minute)
Time frame: Week 0 - Week 36
Change from baseline in oxygen saturation (%)
Time frame: Week 0 - Week 36
Change from baseline in body weight (kg)
Time frame: Week 0 - Week 36
Change from baseline in body mass index (kg/m^2)
Time frame: Week 0 - Week 36
Change from baseline in body temperature (°C)
Time frame: Week 0- Week 36
Change from baseline in clinical chemistry laboratory assessments
Time frame: Week 0 - Week 36
Clinical chemistry assessments will include serum chemistry (such as sodium, potassium, urea, creatinine) and liver function parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin.
Change from baseline in haematology laboratory parameters
Time frame: Week 0 - Week 36
Haematology assessments will include haemoglobin, white blood cell count, differential white blood cell counts and platelet count
Change from baseline in coagulation laboratory parameters
Time frame: Week 0 - Week 36
Coagulation assessments will include activated partial thromboplastin time, international normalised ratio, prothrombin time and fibrinogen
Change from baseline in urinalysis parameters
Time frame: Week 0 - Week 36
Urinalysis assessments will include protein, pH, blood, glucose and leucocytes
Change from baseline in electrocardiogram QT interval
Time frame: Week 0 - Week 36
Electrocardiogram assessments will include evaluation of QT interval corrected using Fridericia's formula (QTcF)
WIN378 Serum concentration (PK)
Time frame: Week 0 to week 36
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Miami Lakes, Florida
- North Dartmouth, Massachusetts
- Charlotte, North Carolina
- McKinney, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations