COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Respiratory Disease, Monoclonal Antibody, Inflammation, TSLP, Moderate - Severe
Brief 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)
Detailed description
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.
Interventions
DRUGWIN378
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
DRUGPlacebo
Placebo matching WIN378
Sponsors
Windward Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Sequential Assignment
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | 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) | 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 |
Countries
Argentina, United States
Contacts
CONTACTJuliana Hutchinson, MSc
STUDY_DIRECTOROmar Khwaja, MD
Windward Bio
Outcome results
None listed