A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
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
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
Treatments tested in this trial
- WIN378
- Placebo
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov