Resumen

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).

Descripción detallada

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and pharmacokinetics of WIN378 in adult participants with moderate to severe asthma. Participants will continue their standard background asthma therapy according to GINA Steps 3-5. Eligible participants will be randomized to receive WIN378 or placebo administered subcutaneously over a 48-week treatment period, followed by a 12-week safety follow-up.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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 of ≥ 30% and ≤ 90%, predicted at two visits at Screening
Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)

Criterios de exclusión

Participants with a known, pre-existing, clinically important lung condition other than asthma
Active tuberculosis or treatment required for tuberculosis within 12 months
Current or former smokers ≥10 pack years
History of cancer
Receipt of any marketed biologic agent within 4 months or 5 half-lives prior to screening; receipt of immunoglobulin or blood products within 30 days prior to screening or during the Screening Run-in period; receipt of any live or attenuated vaccines within 15 days prior to screening
Helminth infection within 24 weeks prior to screening
Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period
Participants who are pregnant, lactating or breastfeeding

Intervenciones

drug

WIN378

WIN378 is a fully human, long-acting monoclonal antibody that binds to thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving asthma control over an extended dosing interval.

drug