Trials / Recruiting
RecruitingNCT07363642
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 12 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.
Detailed description
This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential and safety of stepping down background maintenance therapy following the initiation of Tezepelumab treatment in Chinese patients with maintenance of asthma control. This study will be conducted at approximately 70 study sites in China. The study duration for each patient will be up to 52 weeks. Approximately 400 patients with severe asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs or theophylline will be enrolled into this single arm study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tezepelumab | Severe asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment |
Timeline
- Start date
- 2026-01-28
- Primary completion
- 2027-08-07
- Completion
- 2029-03-31
- First posted
- 2026-01-23
- Last updated
- 2026-03-18
Locations
75 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07363642. Inclusion in this directory is not an endorsement.