A Phase 2 interventional study of WIN378 and Placebo in COPD (Chronic Obstructive Pulmonary Disease), sponsored by Windward Bio. Recruiting at 21 sites in 2 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
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.
Exclusion Criteria:
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
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Pulmonary Disease, Chronic Obstructive→
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