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NCT07646587

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

Recruiting
PHASE2Ages 40–80InterventionalTreatment
Windward Bio
~105 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:WIN378Placebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse Events (AEs)
Measured over Week 0 - Week 36
+15 more outcomes measured

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Explore related trials

Chronic Obstructive Pulmonary DiseaseEosinophiliaTSLP Gene

Where it's being run

4 sites across 4 states
Florida1
Massachusetts1
North Carolina1
Texas1

Study leadership

  • Omar Khwaja, MD · STUDY_DIRECTOR · Windward Bio

Who to contact

Juliana Hutchinson, MSc
[email protected]
+4161 551 75 75
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 assessmentsWeek 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 parametersWeek 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 parametersWeek 0 - Week 36

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

  • Change from baseline in urinalysis parametersWeek 0 - Week 36

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

  • Change from baseline in electrocardiogram QT intervalWeek 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