Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
NCT ID: NCT05398263
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
125 participants
INTERVENTIONAL
2022-08-09
2025-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tezepelumab
Tezepelumab subcutaneous injection, in an accessorised pre-filled syringe.
Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection, in an accessorised pre-filled syringe.
Placebo
Placebo subcutaneous injection
Interventions
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Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
3. Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1.
4. Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1.
5. Additional maintenance asthma controller medications are allowed. The use of these medications must be documented for at least 3 months prior to Visit 1.
6. Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1.
7. Morning pre- bronchodilator (BD) FEV1 must be \< 80% predicted normal at Visit 1 or Visit 2.
8. Evidence of asthma as documented by either:
a)Post-BD responsiveness test result: FEV1 ≥12% and ≥200 mL documented either in the previous 60 months prior to or at Visit 1 or at Visit 2 or at Visit 3; OR b)Airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction \[PC20\] of \<8 mg/mL) documented in the 60 months prior to Visit 1.
9. Blood eosinophils at Visit 1 ≥150 cells/μL or documented EOS ≥300 cells/μL within 12 months prior to Visit 1.
10. Participants must have a history of at least 1 asthma exacerbation event within 24 months prior to Visit 1.
11. Participants must have received the optimised OCS dose for at least 2 weeks prior to randomisation.
Exclusion Criteria
2. Any disorder that is not stable in the opinion of the Investigator and could: a. Affect the safety of the participant throughout the study; b. Influence the findings of the study or the interpretation; c. Impede the participant's ability to complete the entire duration of study.
3. History of cancer: a. Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1; b. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
4. Asthma exacerbation, requiring use of systemic corticosteroids or increase in the maintenance dose of OCS finalized within 30 days prior to Visit 1.
5. Clinically significant infection requiring treatment with systemic antibiotics or antiviral medications finalized \< 2 weeks before Visit 1 or during the run-in period.
6. Participants with evidence of active COVID-19 infection during run-in period and optimisation.
7. A helminth 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.
8. A participant who is on SABA maintenance treatment within 30 days prior to Visit 1.
9. Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \<10 pack years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
10. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
11. COVID-19 vaccination within 28 days prior to randomisation.
12. Tuberculosis requiring treatment within the 12 months prior to Visit 1.
13. During the optimisation period, asthma control reached at an OCS dose of \<7.5 mg or \>30 mg and/or 3 consecutive dose reductions after which asthma control was still obtained.
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Newport Beach, California, United States
Research Site
Denver, Colorado, United States
Research Site
Newark, Delaware, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Lincoln, Nebraska, United States
Research Site
The Bronx, New York, United States
Research Site
El Paso, Texas, United States
Research Site
Kingwood, Texas, United States
Research Site
Botucatu, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
Research Site
São Bernardo do Campo, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
Research Site
Ajax, Ontario, Canada
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Québec, Quebec, Canada
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Curicó, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Brno, , Czechia
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Hradec Králové, , Czechia
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Jindřichův Hradec, , Czechia
Research Site
Moravský Krumlov, , Czechia
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Olomouc, , Czechia
Research Site
Ostrava, , Czechia
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Ajmer, , India
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Kanpur, , India
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Vadodara, , India
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Guadalajara, , Mexico
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Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Mexico City, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Veracruz, , Mexico
Research Site
Lima, , Peru
Research Site
Bialystok, , Poland
Research Site
Bychawa, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Chęciny, , Poland
Research Site
Grudziądz, , Poland
Research Site
Ostrowiec Świętokrzyski, , Poland
Research Site
Poznan, , Poland
Research Site
Rzeszów, , Poland
Research Site
Sosnowiec, , Poland
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Bang Kra So, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Countries
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Related Links
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Call center number: 866-914-6996 Email address: [email protected]
Other Identifiers
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05398263
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-504648-33
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504648-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-006691-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5180C00024
Identifier Type: -
Identifier Source: org_study_id
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