Phase 3b Study to Evaluate Stepping Down Asthma Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab in China

What this Trial Is About

This research aims to evaluate the potential for patients with severe asthma treated with Tezepelumab to safely reduce their background maintenance asthma medications while keeping their asthma symptoms under control. It is a Phase 3b, single-arm, multi-center study conducted in China involving about 400 patients aged 12 to 80 years who have severe asthma and are on medium to high doses of ICSLABA therapy with or without additional controllers. The study focuses on Chinese patients maintaining asthma control after starting Tezepelumab treatment. Participants will receive Tezepelumab treatment while maintaining their current asthma medications initially. The study will observe the potential to step down or reduce these background therapies over time. The treatment period lasts up to 52 weeks, during which researchers will monitor how well patients maintain asthma control while reducing their standard controller regimen. This single-arm study does not include a comparator group. Participants will be involved for up to 52 weeks, during which their lung function, asthma symptom control, exacerbation rates, and quality of life will be assessed regularly. Various questionnaires, pulmonary function tests, symptom diaries, and biomarker evaluations will be conducted from the start of treatment through week 52. Safety and efficacy measures will be monitored throughout the study to assess the impact of reducing background asthma medications while on Tezepelumab.

Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab