Windward Bio
This is a global Phase 2 study divided in two parts. Part A is a double-blind, randomized dose-range finding study in adults with moderate to severe asthma to confirm the dosing regimen of WIN378 that can be tested in future pivotal trials for efficacy and safety. Part B is a pivotal double-blind, randomized study to demonstrate the efficacy and safety of WIN378 in adults with severe uncontrolled asthma. Two dose levels of WIN378 will be tested against placebo to evaluate AAER, lung function, asthma control, asthma-related quality of life and other important efficacy endpoints.
The main purpose of this global study is to assess whether WIN378, an ultra-long-acting medicine for people with asthma, reduces the annualized rate of asthma exacerbations using the doses identified from an interim analysis of Part A of the study. WIN378 blocks the action of a protein called TSLP, which causes inflammation in the lung and may contribute to asthma control and symptoms. The study has two parts. Part A is evaluating three doses of WIN378 in adults with moderate or severe asthma to evaluate: 1) how WIN378 is handled by your body (pharmacokinetics), 2) the safety of WIN378 and 3)…
Inclusion Criteria: * Written Informed Consent Form * Females that are not pregnant or breastfeeding with following condition: not a woman of childbearing potential or woman of childbearing potential using a highly effective contraception method * Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening * Airflow limitation as indicated by pre-BD FEV1 value: PART A of ≥ 30% and ≤ 90%, predicted; PART B of ≥ 30% and ≤ 80%, predicted * PART A Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/…
WIN378 is a fully human, ultra-long-acting monoclonal antibody given twice-yearly that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over the extended dosing interval.
A sham injection consisting of placebo to mask WIN378.