drugset
drugset / Trial / NCT06473779

Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.

NCT06473779 ↗

Phase 3 Active not recruiting 326 enrolled AstraZeneca Fortrea · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma.. Study details include: 1. The study duration will be up to 72 weeks. 2. The treatment duration will be up to 68 weeks. 3. The visit frequency will be once every 4 weeks (Q4W).

Timeline

Start
2024-09-30
Primary completion
2027-06-25
Completion
2027-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Tezepelumab Monoclonal antibody 210 mg Subcutaneous
Background Albuterol/budesonide Unknown 80 ug Inhaled
Background Albuterol/budesonide Unknown 90 ug Inhaled
Background Budesonide/formoterol Unknown 4.5 ug Inhaled
Background Budesonide/formoterol Unknown 80 ug Inhaled
Background Budesonide/formoterol Unknown 160 ug Inhaled
Background Mannitol Diagnostic / imaging agent 0 mg Other
Background Mannitol Diagnostic / imaging agent 5 mg Other
Background Mannitol Diagnostic / imaging agent 10 mg Other
Background Mannitol Diagnostic / imaging agent 20 mg Other
Background Mannitol Diagnostic / imaging agent 40 mg Other
Background Salbutamol Unknown 100 ug Inhaled

Indications

asthma