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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
WIN378 Dose 1 		WIN378 SC injections will be administered
  • Drug: WIN378
    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
Experimental
WIN378 Dose 2 		WIN378 SC injections will be administered
  • Drug: WIN378
    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
Experimental
Placebo 		Placebo SC injections will be administered
  • Drug: Placebo
    Placebo matching WIN378

Recruiting Locations

WB Contracted Clinical Research Site
Miami Lakes, Florida 33014

WB Contracted Clinical Research Site
Charlotte, North Carolina 28277

WB Contracted Clinical Research Site
McKinney, Texas 75069

More Details

Status
Recruiting
Sponsor
Windward Bio

Study Contact

Juliana Hutchinson, MSc
+4161 551 75 75
clinical.trial.enquiry@windwardbio.com

Detailed Description

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, and pharmacokinetics of WIN378 in adult participants with moderate - severe chronic obstructive pulmonary disease (COPD). Participants will continue their standard background COPD therapy. Eligible participants will receive doses of WIN378 or placebo over a 24-week treatment period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.