A Phase 2 interventional study of WIN378 and Placebo in COPD (Chronic Obstructive Pulmonary Disease), sponsored by Windward Bio. Recruiting at 32 sites in 2 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Windward Bio · Phase 2, Interventional, and Treatment
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)
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, and pharmacokinetics of WIN378 in adult participants with moderate - severe chronic obstructive pulmonary disease (COPD). Participants will continue their standard background COPD therapy. Eligible participants will receive doses of WIN378 or placebo over a 24-week treatment period.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 105 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Windward Bio is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
WIN378 SC injections will be administered
Drug: WIN378
WIN378 SC injections will be administered
Drug: WIN378
Placebo SC injections will be administered
Drug: Placebo
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
Placebo matching WIN378
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
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.
Time frame: Week 0 - Week 36
Change from baseline in haematology laboratory parameters
Haematology assessments will include haemoglobin, white blood cell count, differential white blood cell counts and platelet count
Time frame: Week 0 - Week 36
Change from baseline in coagulation laboratory parameters
Coagulation assessments will include activated partial thromboplastin time, international normalised ratio, prothrombin time and fibrinogen
Time frame: Week 0 - Week 36
Change from baseline in urinalysis parameters
Urinalysis assessments will include protein, pH, blood, glucose and leucocytes
Time frame: Week 0 - Week 36
Change from baseline in electrocardiogram QT interval
Electrocardiogram assessments will include evaluation of QT interval corrected using Fridericia's formula (QTcF)
Time frame: Week 0 - Week 36
WIN378 Serum concentration (PK)
Time frame: Week 0 to week 36
Change from baseline in Blood Eosinophil Count
Time frame: Week 0 to Week 24
Change in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Week 0 to Week 24
Change in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Week 0 to Week 24
Change in Pre and Post Bronchodilator Forced Vital Capacity (FVC)
Time frame: Week 0 to Week 24
Incidence and magnitude of anti-drug antibodies to WIN 378
Time frame: Week 0 to Week 36
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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