Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult… (NCT05274815) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
United States305 participantsStarted 2022-05-17
Plain-language summary
This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.
Who can participate
Age range18 Years – 80 Years
SexALL
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Main inclusion criteria:
* Age 18-80 years.
* Documented physician diagnosed asthma requiring continuous treatment with high-dose ICS plus a LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers.
* Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1.
* Participant should be on a stable maintenance OCS dose for at least 4 weeks prior to Visit 1.
* Documented history of at least 1 asthma exacerbation event within 12 months prior to Visit 1.
Other inclusion criteria per protocol apply.
Main exclusion criteria:
* Pulmonary disease or systemic diseases, other than asthma associated with elevated peripheral EOS counts.
* Any disorder or major physical impairment that is not stable and could affect the safety of the participant throughout the study, influence the findings of the study or the interpretation, or impede the participant's ability to complete the entire duration of study.
* History of cancer.
* History of a clinically significant infection requiring treatment with antibiotics, antiviral or additional corticosteroid medications finalised \< 2 weeks before Visit 1.
* A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
* Current smokers or par…
What they're measuring
1
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
Timeframe: Week 28 and Week 52
2
Proportion of the Participants Who Reduced Daily Prescribed Maintenance OCS Dose to ≤5 mg/Day Without Loss of Asthma Control at Week 28 and Week 52