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.

A Multicentre, Randomised, Open-Label, Parallel-Group, Phase IIIb Study to Assess the Potential for Tezepelumab-treated Patients With Severe Asthma to Reduce Background Therapy While Sustaining Asthma Control and Clinical Remission

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multicentre, randomised, open-label, parallel-group, phase IIIb study to assess the potential for tezepelumab-treated patients to (1) reduce maintenance therapy without the loss of asthma control at Week 56, among those who demonstrated asthma control or low biomarkers at Week 24, and (2) be in asthma control and have characteristics of clinical remission at Week 24. Approximately 65 sites in 10 countries will enrol adult and adolescent patients with severe uncontrolled asthma. The study is divided into 5 phases as described below: * Screening/Run-in Phase (from Week -4 until Week 0, up to 4 Weeks) * Treatment Induction Phase (Week 0 to Week 4) * Treatment Continuation Phase (Week 4 to Week 24) * Tezepelumab Treatment With or Without ICS Step-down Therapy Phase (Week 24 to Week 56) * Maintenance Phase (Week 56 to Week 72)

Conditions

• Severe Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tezepelumab	IMP. Subcutaneous injection. Unit dose strengths 210 mg.
COMBINATION_PRODUCT	Budesonide/formoterol	AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation
COMBINATION_PRODUCT	Albuterol/budesonide (AIRSUPRA®)	AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only.
COMBINATION_PRODUCT	Mannitol	NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules
COMBINATION_PRODUCT	Salbutamol	AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation

Timeline

• Start date: 2024-09-30
• Primary completion: 2027-06-25
• Completion: 2027-06-25
• First posted: 2024-06-25
• Last updated: 2026-03-12

Locations

70 sites across 12 countries: United States, Argentina, Belgium, Bulgaria, Canada, Denmark, France, Germany, Italy, Mexico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study