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

ConditionCOPD (Chronic Obstructive Pulmonary Disease)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorWindward Bio

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: WIN378 Dose 1Experimental treatment 1 intervention
Group B: WIN378 Dose 2Experimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Windward Bio

Lead sponsor

Source ClinicalTrials.gov
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