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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Windward Bio • ClinicalTrials.gov ID: NCT07646587

Registry updated: 2026-09-15
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Description

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)

Interventions

  • 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

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

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Locations

  • WB Contracted Clinical Research Site — Los Angeles, California, United States
  • WB Contracted Clinical Research Site — Miami Lakes, Florida, United States
  • WB Contracted Clinical Research Site — North Dartmouth, Massachusetts, United States
  • WB Contracted Clinical Research Site — Charlotte, North Carolina, United States
  • WB Contracted Clinical Research Site — Medford, Oregon, United States
  • WB Contracted Clinical Research Site — DuBois, Pennsylvania, United States
  • WB Contracted Clinical Research Site — McKinney, Texas, United States
  • WB Contracted Clinical Research Site — Waxahachie, Texas, United States
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires, Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires, Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires, Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires, Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires, Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires, Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires F.D., Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Buenos Aires F.D., Argentina
  • WB Contracted Clinical Research Site — Buenos Aires, Mendoza Province, Argentina
  • WB Contracted Clinical Research Site — Mendoza, Mendoza Province, Argentina
  • WB Contracted Clinical Research Site — Rosario, Santa Fe Province, Argentina
  • WB Contracted Clinical Research Site — Rosario, Santa Fe Province, Argentina
  • WB Contracted Clinical Research Site — Santa Fe, Santa Fe Province, Argentina
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record