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Study details
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A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

AstraZeneca
NCT IDNCT06023589ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

231

Study length

about 7 years

Ages

5–11

Locations

30 sites in AL, AR, AZ +12

What this study is about

This trial is testing a treatment called tezepelumab compared to a placebo (inactive pill) in children with severe asthma. The goal is to see if tezepelumab helps improve asthma control and is safe for this age group.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Placebo
  • 2.Receive Tezepelumab

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

tezepelumab

Endpoints

Secondary: Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score, Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-(S)-IA) total score, Change from baseline in blood eosinophil count, Change from baseline in fractional exhaled nitric oxide (FeNO), Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN), Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF), Change from baseline in total serum IgE, Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score

Body systems

Respiratory