Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Placebo: A sham injection consisting of placebo to mask WIN378.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Number of participants with treatment-emergent adverse events (TEAEs) during the study — Week 0 - Week 60
• Number of participants with treatment-emergent serious adverse events (TESAEs) during the study — Week 0 - Week 60
• Number of participants with abnormal vital signs during the study — Week 0 - Week 60
• Number of participants with abnormal laboratory assessments during the study — Week 0 - Week 60
• Number of participants with Clinically significant abnormal ECG results during the study — Week 0 - Week 60
• WIN 378 Pharmacokinetics: concentration at trough [Ctrough] — Week 0 - Week 60
• WIN 378 Pharmacokinetics: area under the concentration time curve [AUC] — Week 0 - Week 60
• WIN 378 Pharmacokinetics: maximum observed concentration [Cmax]) — Week 0 - Week 60
• Number of participants with positive anti-drug antibodies (ADA) during the study — Week 0 - Week 60

Trial sites (73)

+ 33 more sites — see the full list on the official registry below.