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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 40 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official 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

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Being tested

WIN378, Placebo

Keywords

COPD, Chronic Obstructive Pulmonary Disease, Respiratory Disease, Monoclonal Antibody, Inflammation, TSLP, Moderate - Severe

Medical subject headings

Pulmonary Disease, Chronic Obstructive, Respiration Disorders, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• WIN378Drug

  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

• PlaceboDrug

  Placebo matching WIN378

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of participants with Adverse Events (AEs)

   Measured: Week 0 - Week 36

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

   Measured: Week 0 - Week 36

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

   Measured: Week 0 - Week 36

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

   Measured: Week 0 - Week 36

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

   Measured: Week 0 - Week 36

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

   Measured: Week 0 - Week 36

7. Change from baseline in oxygen saturation (%)

   Measured: Week 0 - Week 36

8. Change from baseline in body weight (kg)

   Measured: Week 0 - Week 36

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

   Measured: Week 0 - Week 36

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

    Measured: Week 0- Week 36

11. 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.

    Measured: Week 0 - Week 36

12. Change from baseline in haematology laboratory parameters

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

    Measured: Week 0 - Week 36

13. Change from baseline in coagulation laboratory parameters

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

    Measured: Week 0 - Week 36

14. Change from baseline in urinalysis parameters

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

    Measured: Week 0 - Week 36

15. Change from baseline in electrocardiogram QT interval

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

    Measured: Week 0 - Week 36

16. WIN378 Serum concentration (PK)

    Measured: Week 0 to week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Jun 2026
2. Study start2 Jun 2026
3. Primary completion17 Dec 2027 (estimated)
4. Study completion7 Jan 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.