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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1333-4974 | Other Identifier | UTN, World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WIN378 Dose 1 | Experimental | WIN378 SC injections will be administered |
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| WIN378 Dose 2 | Experimental | WIN378 SC injections will be administered |
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| Placebo | Experimental | Placebo SC injections will be administered |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIN378 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Blood Eosinophil Count | Week 0 to Week 24 | |
| Change in Fractional Exhaled Nitric Oxide (FeNO) | Week 0 to Week 24 | |
| Change in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana Hutchinson, MSc | Contact | +4161 551 75 75 | clinical.trial.enquiry@windwardbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Omar Khwaja, MD | Windward Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WB Contracted Clinical Research Site | Recruiting | Miami Lakes | Florida | 33014 | United States | |
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| Label | URL |
|---|---|
| Link to Sponsor Website | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012120 | Respiration Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Sequential Assignment
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Double-blind
| Placebo | Drug | Placebo matching WIN378 |
|
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.
| 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 | 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 | Week 0 - Week 36 |
| Change from baseline in urinalysis parameters | Urinalysis assessments will include protein, pH, blood, glucose and leucocytes | 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) | Week 0 - Week 36 |
| WIN378 Serum concentration (PK) | Week 0 to week 36 |
| Week 0 to Week 24 |
| Change in Pre and Post Bronchodilator Forced Vital Capacity (FVC) | Week 0 to Week 24 |
| Incidence and magnitude of anti-drug antibodies to WIN 378 | Week 0 to Week 36 |
| WB Contracted Clinical Research Site |
| Recruiting |
| North Dartmouth |
| Massachusetts |
| 02747 |
| United States |
| WB Contracted Clinical Research Site | Recruiting | Charlotte | North Carolina | 28277 | United States |
| WB Contracted Clinical Research Site | Recruiting | McKinney | Texas | 75069 | United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |