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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Placebo: Placebo matching WIN378

Study 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)

Eligibility

Primary outcome measure(s)

• Number of participants with Adverse Events (AEs) — Week 0 - Week 36
• Number of participants with Serious Adverse Events (SAEs) — Week 0 - Week 36
• Change from baseline in systolic blood pressure (mmHg) — Week 0 - Week 36
• Change from baseline in diastolic blood pressure (mmHg) — Week 0 - Week 36
• Change from baseline in pulse rate (beats/minute) — Week 0 - Week 36
• Change from baseline in respiratory rate (breaths/minute) — Week 0 - Week 36
• Change from baseline in oxygen saturation (%) — Week 0 - Week 36
• Change from baseline in body weight (kg) — Week 0 - Week 36
• Change from baseline in body mass index (kg/m^2) — Week 0 - Week 36
• Change from baseline in body temperature (°C) — Week 0- Week 36
• Change from baseline in clinical chemistry laboratory assessments — 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 — 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 — 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 — Week 0 - Week 36
  Urinalysis assessments will include protein, pH, blood, glucose and leucocytes
• Change from baseline in electrocardiogram QT interval — Week 0 - Week 36
  Electrocardiogram assessments will include evaluation of QT interval corrected using Fridericia's formula (QTcF)
• WIN378 Serum concentration (PK) — Week 0 to week 36

Trial sites (32)

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