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

NCT05398263 | Terminated Phase 3 FDA Drug

• 5 other identifiers: D5180C00024053982632023-504648-332023-504648-33-002021-006691-17
• Study Type: interventional
• Target: 125
• Locations: 12 countries
• Sites: 64

Brief Summary

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Conditions

Asthma

Keywords

Asthma; Severe Asthma; Oral Corticosteroid Dependent Asthma; Tezepelumab; Phase 3 Study; Reducing Oral Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control.

  Categorised percent reduction from baseline at Week 28. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}\*100%, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to \<90% reduction, ≥50% to \<75% reduction, \>0% to \<50% reduction, and, no change or any increase.

  Baseline to Week 28

Secondary Outcomes (15)

• Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) at Week 28

  Baseline to Week 28

• Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28

  Baseline to Week 28

• Proportion of subjects with daily OCS dose ≤5 mg at Week 28

  Week 28

• Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28

  Baseline to Week 28

• Annualised asthma exacerbation rate (AAER) over 28 weeks

  Baseline to Week 28

Study Arms (2)

Tezepelumab

EXPERIMENTAL

Tezepelumab subcutaneous injection, in an accessorised pre-filled syringe.

Biological: Tezepelumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection, in an accessorised pre-filled syringe.

Other: Placebo

Interventions

Tezepelumab BIOLOGICAL

Tezepelumab subcutaneous injection

Tezepelumab

Placebo OTHER

Placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 to 80 years of age.
• Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
• Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1.
• Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1.
• Additional maintenance asthma controller medications are allowed. The use of these medications must be documented for at least 3 months prior to Visit 1.
• 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.
• Morning pre- bronchodilator (BD) FEV1 must be \< 80% predicted normal at Visit 1 or Visit 2.
• 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.
• Blood eosinophils at Visit 1 ≥150 cells/μL or documented EOS ≥300 cells/μL within 12 months prior to Visit 1.
• Participants must have a history of at least 1 asthma exacerbation event within 24 months prior to Visit 1.
• Participants must have received the optimised OCS dose for at least 2 weeks prior to randomisation.

You may not qualify if:

• Any clinically important pulmonary disease other than asthma.
• 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.
• 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.
• Asthma exacerbation, requiring use of systemic corticosteroids or increase in the maintenance dose of OCS finalized within 30 days prior to Visit 1.
• Clinically significant infection requiring treatment with systemic antibiotics or antiviral medications finalized \< 2 weeks before Visit 1 or during the run-in period.
• Participants with evidence of active COVID-19 infection during run-in period and optimisation.
• 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.
• A participant who is on SABA maintenance treatment within 30 days prior to Visit 1.
• 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.
• 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.
• COVID-19 vaccination within 28 days prior to randomisation.
• Tuberculosis requiring treatment within the 12 months prior to Visit 1.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Amgen: collaborator

Study Sites (64)

Research Site

Newport Beach, California, 92663, United States

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Denver, Colorado, 80206, United States

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Newark, Delaware, 19713, United States

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Hialeah, Florida, 33016, United States

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Miami Lakes, Florida, 33014, United States

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Lincoln, Nebraska, 68510, United States

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The Bronx, New York, 10459, United States

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El Paso, Texas, 79902, United States

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Kingwood, Texas, 77339, United States

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Botucatu, 18618-686, Brazil

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Curitiba, 80730-150, Brazil

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Porto Alegre, 90035074, Brazil

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Porto Alegre, 91350-200, Brazil

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Salvador, 40060-330, Brazil

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São Bernardo do Campo, 09715090, Brazil

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São Paulo, 01223-001, Brazil

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Sorocaba, 18040-425, Brazil

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Ajax, Ontario, L1S 2J5, Canada

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Québec, Quebec, G1V4G5, Canada

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Curicó, 3341643, Chile

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Santiago, 7500010, Chile

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Santiago, 7500588, Chile

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Santiago, 7500691, Chile

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Santiago, 7500692, Chile

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Santiago, 7500698, Chile

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Santiago, 7750495, Chile

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Santiago, 8241479, Chile

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Brno, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Moravský Krumlov, 67201, Czechia

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Olomouc, 779 00, Czechia

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Ostrava, 700 30, Czechia

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Ajmer, 305001, India

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Kanpur, 208002, India

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Vadodara, 390022, India

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Guadalajara, 44100, Mexico

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Guadalajara, 44130, Mexico

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Guadalajara, 44200, Mexico

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Mexico City, 0 3100, Mexico

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Monterrey, 64460, Mexico

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San Luis Potosí City, 78250, Mexico

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Veracruz, 91910, Mexico

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Lima, 15046, Peru

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Bialystok, 15-704, Poland

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Bychawa, 23100, Poland

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Bydgoszcz, 85-231, Poland

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Chęciny, 26-060, Poland

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Grudziądz, 86-300, Poland

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Ostrowiec Świętokrzyski, 27-400, Poland

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Poznan, 61-578, Poland

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Rzeszów, 35-205, Poland

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Sosnowiec, 41-208, Poland

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Seoul, 05505, South Korea

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Seoul, 07061, South Korea

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Seoul, 143-729, South Korea

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Suwon, 16499, South Korea

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Bang Kra So, 11000, Thailand

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Bangkok, 10330, Thailand

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Hat Yai, 90110, Thailand

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Ankara, 06620, Turkey (Türkiye)

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Bursa, 16059, Turkey (Türkiye)

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Istanbul, 34899, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Related Links

• Call center number: 866-914-6996 Email address: az-asthmatrials@careboxhealth.com

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 2:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: May 31, 2022
• Study Start: August 9, 2022
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level datain an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

ME (7); IN (3); CA (2); BR (8); PE (1); US (9); CZ (6); KR (4); CL (8); TH (3); TU (4); PL (9)