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Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

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NCT05398263 · results posted

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Amgen.

Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
125actual
Sites
64
Countries
Brazil, Canada, Chile +9

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-08-09actualWhen the study began enrolling
Primary completion2025-03-24actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-03-24actualThe whole study's end, after follow-up
First posted2022-05-31actualWhen this record first appeared on the registry
Results posted2026-06-18actualWhen the sponsor posted results to the registry
Record updated2026-06-18actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Asthma

Interventions

  • Biological: Tezepelumab
  • Other: Placebo

Primary outcome

what the primary-completion date above is the date OF
Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control.
measured Baseline to Week 28

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2023-03-28 · 1.0 MB · Prot_004.pdf
Statistical Analysis Planposted 2025-02-05 · 12.6 MB · SAP_005.pdf

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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