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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

NCT06023589 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-04-30

No results posted yet for this study

Summary

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

Conditions

Interventions

BIOLOGICAL

Tezepelumab

Participants will be receiving subcutaneous injection of tezepelumab

OTHER

Placebo

Participants will be receiving subcutaneous injection of matching placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2028-05-31
Completion
2030-08-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • Colombia
  • France
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023589 on ClinicalTrials.gov