RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests doses of WIN378, a long-acting medicine, in adults with moderate to severe COPD, a lung disease that makes breathing hard. WIN378 blocks a protein that causes swelling in the lungs. The study checks safety, how the body handles the medicine, and its effects on lung swelling, breathing, and COPD control.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 40 to 80 years old.
  • Have breathing test results in the required range after using medicine that opens the airways: FEV1/FVC below 0.70 and FEV1 at 30–80% of the expected value.
  • Have used a stable three-medicine inhaled COPD treatment (ICS/LABA/LAMA) for at least 3 months.
  • Have stopped smoking for at least 6 months and smoked at least 10 pack-years in the past, such as 1 pack a day for 10 years.
  • Have a high count of eosinophils, a type of white blood cell.
  • Have weight and BMI, a measure of weight compared with height, within the allowed range.

Who can't join

  • Have another significant lung disease besides COPD.
  • Have other significant health conditions or infections that the study doctor thinks could affect safety or the study.
  • Have significant heart or blood vessel disease.
  • Have had a recent breathing infection or COPD flare-up.
  • Have used approved or experimental biologic COPD medicines without enough time for them to leave the body (at least 5 drug half-lives).
  • Are pregnant or breastfeeding.
  • Currently smoke or have a diagnosed substance use disorder.
  • Have any other condition or situation that the study doctor thinks would make joining unsafe or affect the study’s reliability.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (8)

CA

FL

MA

NC

OR

PA

TX