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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05398263




Registration number
NCT05398263
Ethics application status
Date submitted
26/05/2022
Date registered
31/05/2022

Titles & IDs
Public title
Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Scientific title
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 (SUNRISE)
Secondary ID [1] 0 0
05398263
Secondary ID [2] 0 0
D5180C00024
Universal Trial Number (UTN)
Trial acronym
SUNRISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tezepelumab
Other interventions - Placebo

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

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


Treatment: Other: Tezepelumab
Tezepelumab subcutaneous injection

Other interventions: Placebo
Placebo subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control.
Timepoint [1] 0 0
Baseline to Week 28
Secondary outcome [1] 0 0
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) at Week 28
Timepoint [1] 0 0
Baseline to Week 28
Secondary outcome [2] 0 0
Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28
Timepoint [2] 0 0
Baseline to Week 28
Secondary outcome [3] 0 0
Proportion of subjects with daily OCS dose =5 mg at Week 28
Timepoint [3] 0 0
Week 28
Secondary outcome [4] 0 0
Proportion of subjects with =50% reduction from baseline in daily OCS dose at Week 28
Timepoint [4] 0 0
Baseline to Week 28
Secondary outcome [5] 0 0
Annualised asthma exacerbation rate (AAER) over 28 weeks
Timepoint [5] 0 0
Baseline to Week 28
Secondary outcome [6] 0 0
Time to first asthma exacerbation
Timepoint [6] 0 0
Baseline to Week 28
Secondary outcome [7] 0 0
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score at Week 28
Timepoint [7] 0 0
Baseline to Week 28
Secondary outcome [8] 0 0
Change from baseline in weekly mean home peak expiratory flow (PEF) (morning and evening) at Week 28
Timepoint [8] 0 0
Baseline to Week 28
Secondary outcome [9] 0 0
Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) total score at Week 28
Timepoint [9] 0 0
Baseline to Week 28
Secondary outcome [10] 0 0
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28
Timepoint [10] 0 0
Baseline to Week 28
Secondary outcome [11] 0 0
Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28
Timepoint [11] 0 0
Baseline to Week 28
Secondary outcome [12] 0 0
Change from baseline in peripheral blood eosinophils at Week 28
Timepoint [12] 0 0
Baseline to Week 28
Secondary outcome [13] 0 0
Change from baseline in total serum immunoglobulin E (IgE) at Week 28
Timepoint [13] 0 0
Baseline to Week 28
Secondary outcome [14] 0 0
PK: Serum trough concentrations at Week 0, 12 and 28
Timepoint [14] 0 0
Baseline, Week 12 and Week 28
Secondary outcome [15] 0 0
Immunogenicity: Incidence of anti-drug antibodies (ADA) at Week 0, 12, 28, and 40
Timepoint [15] 0 0
Baseline to Week 40

Eligibility
Key inclusion criteria
Main inclusion criteria:

1. Participant must be 18 to 80 years of age.
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.

Other inclusion criteria per protocol apply.

Main exclusion criteria

1. Any clinically important pulmonary disease other than asthma.
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.

Other exclusion criteria per protocol apply.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
207
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
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United States of America
State/province [8] 0 0
Michigan
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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South Carolina
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United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Brazil
State/province [15] 0 0
Botucatu
Country [16] 0 0
Brazil
State/province [16] 0 0
Curitiba
Country [17] 0 0
Brazil
State/province [17] 0 0
Porto Alegre
Country [18] 0 0
Brazil
State/province [18] 0 0
Recife
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio de Janeiro
Country [20] 0 0
Brazil
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Salvador
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Bernardo do Campo
Country [22] 0 0
Brazil
State/province [22] 0 0
Sorocaba
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Chile
State/province [27] 0 0
Curico
Country [28] 0 0
Chile
State/province [28] 0 0
Santiago
Country [29] 0 0
Chile
State/province [29] 0 0
Valparaiso
Country [30] 0 0
Chile
State/province [30] 0 0
Viña del Mar
Country [31] 0 0
Colombia
State/province [31] 0 0
Barranquilla
Country [32] 0 0
Colombia
State/province [32] 0 0
Bogota
Country [33] 0 0
Colombia
State/province [33] 0 0
Cali
Country [34] 0 0
Colombia
State/province [34] 0 0
Medellin
Country [35] 0 0
Czechia
State/province [35] 0 0
Brno
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Czechia
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Hradec Kralove
Country [37] 0 0
Czechia
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Jindrichuv Hradec
Country [38] 0 0
Czechia
State/province [38] 0 0
Moravsky Krumlov
Country [39] 0 0
Czechia
State/province [39] 0 0
Olomouc
Country [40] 0 0
Czechia
State/province [40] 0 0
Ostrava
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India
State/province [41] 0 0
Ajmer
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India
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Aligarh
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India
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Chennai
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India
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Delhi
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India
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Jaipur
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India
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Kanpur
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India
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Kolkata
Country [48] 0 0
India
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Nashik
Country [49] 0 0
India
State/province [49] 0 0
New Delhi
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India
State/province [50] 0 0
Pune
Country [51] 0 0
India
State/province [51] 0 0
Vadodara
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Jeonju
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Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Suwon-si
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Malaysia
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George Town
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Lumpur
Country [58] 0 0
Mexico
State/province [58] 0 0
Chihuahua
Country [59] 0 0
Mexico
State/province [59] 0 0
Guadalajara
Country [60] 0 0
Mexico
State/province [60] 0 0
Mexico City
Country [61] 0 0
Mexico
State/province [61] 0 0
Monterrey
Country [62] 0 0
Mexico
State/province [62] 0 0
Puebla
Country [63] 0 0
Mexico
State/province [63] 0 0
San Luis Potosí
Country [64] 0 0
Mexico
State/province [64] 0 0
Veracruz
Country [65] 0 0
Peru
State/province [65] 0 0
Lima
Country [66] 0 0
Peru
State/province [66] 0 0
Piura
Country [67] 0 0
Peru
State/province [67] 0 0
Pueblo Libre
Country [68] 0 0
Philippines
State/province [68] 0 0
Quezon City
Country [69] 0 0
Philippines
State/province [69] 0 0
Tondo
Country [70] 0 0
Poland
State/province [70] 0 0
Bialystok
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Poland
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Bychawa
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Poland
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Bydgoszcz
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Bedzin
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Checiny
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Grudziadz
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Poland
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Kraków
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Poland
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Lublin
Country [78] 0 0
Poland
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Ostrowiec Swietokrzyski
Country [79] 0 0
Poland
State/province [79] 0 0
Poznan
Country [80] 0 0
Poland
State/province [80] 0 0
Rzeszów
Country [81] 0 0
Poland
State/province [81] 0 0
Sosnowiec
Country [82] 0 0
Thailand
State/province [82] 0 0
Bang Kra So
Country [83] 0 0
Thailand
State/province [83] 0 0
Bangkok
Country [84] 0 0
Thailand
State/province [84] 0 0
Hat Yai
Country [85] 0 0
Thailand
State/province [85] 0 0
Hatyai
Country [86] 0 0
Thailand
State/province [86] 0 0
Mueang Udon Thani
Country [87] 0 0
Turkey
State/province [87] 0 0
Ankara
Country [88] 0 0
Turkey
State/province [88] 0 0
Bursa
Country [89] 0 0
Turkey
State/province [89] 0 0
Istambul
Country [90] 0 0
Turkey
State/province [90] 0 0
Istanbul
Country [91] 0 0
Turkey
State/province [91] 0 0
Izmir
Country [92] 0 0
Turkey
State/province [92] 0 0
Kayseri
Country [93] 0 0
Turkey
State/province [93] 0 0
Yenimahalle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluatedas per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05398263