Last updated 8 days ago

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

105 patients around the world

Available in Argentina, United States

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.

Windward Bio

105Patients around the world

This study is for people with

Chronic obstructive pulmonary disease

Copd

Requirements for the patient

To 80 Years

All Gender

Medical requirements

: 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.

: 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.

StudySirius

SponsorWindward Bio

Study typeInterventional

Conditions

Copd

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07646587