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Recruiting Phase 3 NCT07363642

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

Trial Parameters

Condition Severe Asthma
Sponsor AstraZeneca
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 400
Sex ALL
Min Age 12 Years
Max Age 80 Years
Start Date 2026-01-28
Completion 2027-08-07
Interventions
Tezepelumab

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1.Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\[s\]/guardian\[s\]) and according to international guidelines and/or applicable local guidelines. Age 2. Patient must be aged 12-80 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study. Type of Patient and Disease Characteristics 3. Documented history of physician-diagnosed asthma prior to Visit 1 * Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1, or FEV1≥400 mL variability over time, or positive result of branchial provoc

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