Dose-finding study of WIN378 for moderate to severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of WIN378 in adults with COPD. Participants will continue their standard background COPD therapy and receive WIN378 or placebo over 24 weeks. The study also assesses pharmacodynamics through markers of COPD inflammation in blood and exhaled breath, as well as lung function and disease control. Eligible participants have moderate to severe airflow limitation and elevated eosinophils, with strict exclusion of other significant diseases and recent therapies that could affect outcomes. The goal is to identify a suitable dose range for WIN378 for future studies.

Why it matters

Who can join: the full rules

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

Where it's running

• WB Contracted Clinical Research Site
  Los Angeles, California, United States Recruiting
• WB Contracted Clinical Research Site
  Jacksonville, Florida, United States Recruiting
• WB Contracted Clinical Research Site
  Miami Lakes, Florida, United States Recruiting
• WB Contracted Clinical Research Site
  North Dartmouth, Massachusetts, United States Recruiting
• WB Contracted Clinical Research Site
  Charlotte, North Carolina, United States Recruiting
• WB Contracted Clinical Research Site
  Medford, Oregon, United States Recruiting

Study contacts

• Study coordinator: Juliana Hutchinson, MSc
• Email: clinical.trial.enquiry@windwardbio.com
• Phone: +4161 551 75 75

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.