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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

Study acronym: HORIZON
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 4 of 147 sites
  2. Eligibility criteria expanded, about 26 words Secondary endpoints: details revised at 6 of 20 entries · Site details revised at 1 of 147 sites · Study description expanded, about 3 words Show 3 more changesShow less
    • Secondary endpoints: details revised at 6 of 20 entries
    • Site details revised at 1 of 147 sites
    • Study description expanded, about 3 words
  3. Site details revised at 1 of 147 sitesv35
  4. Trial sites expanded: 143 → 147 locationsv34
  5. Site details revised at 1 of 143 sitesv33
Show 31 earlier versionsHide 31 earlier versions
  1. Site details revised at 4 of 143 sitesv32
  2. Site details revised at 3 of 143 sitesv31
  3. Site details revised at 9 of 143 sitesv30
  4. Study sites: 142 to 143v29
  5. Study sites: 140 to 142v28
  6. Site details revised at 1 of 140 sitesv27
  7. Study sites: 141 to 140v26
  8. Site details revised at 1 of 141 sitesv25
  9. Enrollment target: 372 to 231 Primary endpoint revised · Study sites: 140 to 141 · Eligibility criteria expanded, about 65 words · 2 morev24 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 140 to 141
    • Eligibility criteria expanded, about 65 words
    • Secondary endpoints revised (20)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 18 of 140 sitesv23
  11. Site details revised at 83 of 140 sitesv22
  12. Primary completion date: Apr 23, 2027 to May 31, 2028 Study sites: 123 to 140 · Completion date: Dec 31, 2027 to Aug 23, 2030v21 Show 2 more changesShow less
    • Study sites: 123 to 140
    • Completion date: Dec 31, 2027 to Aug 23, 2030
  13. Study sites: 121 to 123v20
  14. Site details revised at 5 of 121 sitesv19
  15. Study sites: 116 to 121v18
  16. Study sites: 115 to 116v17
  17. Site details revised at 4 of 115 sitesv16
  18. Study sites: 114 to 115v15
  19. Study sites: 105 to 114v14
  20. Study sites: 103 to 105v13
  21. Study sites: 100 to 103v12
  22. Study sites: 99 to 100v11
  23. Study sites: 97 to 99v10
  24. Study sites: 96 to 97v9
  25. Study sites: 92 to 96v8
  26. Study sites: 78 to 92v7
  27. Study sites: 66 to 78v6
  28. Study sites: 54 to 66v5
  29. Site details revised at 3 of 54 sitesv4
  30. Study sites: 53 to 54v3
  31. Study sites: 38 to 53 Primary completion date: May 3, 2027 to Apr 23, 2027 · Completion date: Jan 10, 2028 to Dec 31, 2027v2 Show 2 more changesShow less
    • Primary completion date: May 3, 2027 to Apr 23, 2027
    • Completion date: Jan 10, 2028 to Dec 31, 2027
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Asthma
927 trials monitored
See 32 trials at risk
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.
Trial Details
NCT Number NCT06023589
Lead Sponsor AstraZeneca
Collaborators: Amgen
Conditions Asthma
Enrollment 231 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov