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NCT Number: NCT07646587

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

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)

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

WB Contracted Clinical Research Site, Miami Lakes, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Placebo matching WIN378

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Week 0 - Week 36

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Week 0 - Week 36

  3. Change from baseline in systolic blood pressure (mmHg)

    Time frame: Week 0 - Week 36

  4. Change from baseline in diastolic blood pressure (mmHg)

    Time frame: Week 0 - Week 36

  5. Change from baseline in pulse rate (beats/minute)

    Time frame: Week 0 - Week 36

  6. Change from baseline in respiratory rate (breaths/minute)

    Time frame: Week 0 - Week 36

  7. Change from baseline in oxygen saturation (%)

    Time frame: Week 0 - Week 36

  8. Change from baseline in body weight (kg)

    Time frame: Week 0 - Week 36

  9. Change from baseline in body mass index (kg/m^2)

    Time frame: Week 0 - Week 36

  10. Change from baseline in body temperature (°C)

    Time frame: Week 0- Week 36

  11. Change from baseline in clinical chemistry laboratory assessments

    Time frame: 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.

  12. Change from baseline in haematology laboratory parameters

    Time frame: Week 0 - Week 36

    Haematology assessments will include haemoglobin, white blood cell count, differential white blood cell counts and platelet count

  13. Change from baseline in coagulation laboratory parameters

    Time frame: Week 0 - Week 36

    Coagulation assessments will include activated partial thromboplastin time, international normalised ratio, prothrombin time and fibrinogen

  14. Change from baseline in urinalysis parameters

    Time frame: Week 0 - Week 36

    Urinalysis assessments will include protein, pH, blood, glucose and leucocytes

  15. Change from baseline in electrocardiogram QT interval

    Time frame: Week 0 - Week 36

    Electrocardiogram assessments will include evaluation of QT interval corrected using Fridericia's formula (QTcF)

  16. WIN378 Serum concentration (PK)

    Time frame: Week 0 to week 36

Secondary outcomes

  1. Change from baseline in Blood Eosinophil Count

    Time frame: Week 0 to Week 24

  2. Change in Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: Week 0 to Week 24

  3. Change in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Week 0 to Week 24

  4. Change in Pre and Post Bronchodilator Forced Vital Capacity (FVC)

    Time frame: Week 0 to Week 24

  5. Incidence and magnitude of anti-drug antibodies to WIN 378

    Time frame: Week 0 to Week 36

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana Hutchinson, MSc

CONTACT

[email protected]

+4161 551 75 75

Sponsors and collaborators

Lead sponsor

Windward Bio

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease

Acronym: Sirius

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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