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AsthmaPhase 3SUNRISENCT05398263

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

A Phase 3 study testing Tezepelumab in people with Asthma, run by AstraZeneca at 64 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Asthma
What is being tested?
Tezepelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
64 sitesin 12 countries
Study dates
9 Aug 2022to 24 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

64 sites in 12 countries.

64 sites in 12 countries

United States9 sites

  • Research Site

    Denver, Colorado, 80206

  • Research Site

    El Paso, Texas, 79902

  • Research Site

    Hialeah, Florida, 33016

  • Research Site

    Kingwood, Texas, 77339

  • Research Site

    Lincoln, Nebraska, 68510

  • Research Site

    Miami Lakes, Florida, 33014

  • Research Site

    Newark, Delaware, 19713

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    The Bronx, New York, 10459

Other trials in United States

Poland9 sites

  • Research Site

    Bialystok, 15-704

  • Research Site

    Bychawa, 23100

  • Research Site

    Bydgoszcz, 85-231

  • Research Site

    Chęciny, 26-060

  • Research Site

    Grudziądz, 86-300

  • Research Site

    Ostrowiec Świętokrzyski, 27-400

  • Research Site

    Poznan, 61-578

  • Research Site

    Rzeszów, 35-205

  • Research Site

    Sosnowiec, 41-208

Other trials in Poland

Brazil8 sites

  • Research Site

    Botucatu, 18618-686

  • Research Site

    Curitiba, 80730-150

  • Research Site

    Porto Alegre, 90035074

  • Research Site

    Porto Alegre, 91350-200

  • Research Site

    Salvador, 40060-330

  • Research Site

    São Bernardo do Campo, 09715090

  • Research Site

    São Paulo, 01223-001

  • Research Site

    Sorocaba, 18040-425

Other trials in Brazil

Chile8 sites

  • Research Site

    Chile, 7770484

  • Research Site

    Curicó, 3341643

  • Research Site

    Santiago, 7500010

  • Research Site

    Santiago, 7500588

  • Research Site

    Santiago, 7500691

  • Research Site

    Santiago, 7500698

  • Research Site

    Santiago, 7750495

  • Research Site

    Santiago, 8241479

Other trials in Chile

Mexico7 sites

  • Research Site

    Guadalajara, 44100

  • Research Site

    Guadalajara, 44130

  • Research Site

    Guadalajara, 44200

  • Research Site

    Mexico City, 0 3100

  • Research Site

    Monterrey, 64460

  • Research Site

    San Luis Potosí City, 78250

  • Research Site

    Veracruz, 91910

Other trials in Mexico

Czechia6 sites

  • Research Site

    Brno, 625 00

  • Research Site

    Hradec Králové, 500 05

  • Research Site

    Jindřichův Hradec, 377 01

  • Research Site

    Miroslav, 671 72

  • Research Site

    Olomouc, 779 00

  • Research Site

    Ostrava, 700 30

Other trials in Czechia

South Korea4 sites

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 07061

  • Research Site

    Seoul, 143-729

  • Research Site

    Suwon, 16499

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Research Site

    Ankara, 06620

  • Research Site

    Bursa, 16059

  • Research Site

    Istanbul, 34899

  • Research Site

    Izmir, 35040

Other trials in Turkey (Türkiye)

India3 sites

  • Research Site

    Ajmer, 305001

  • Research Site

    Kanpur, 208002

  • Research Site

    Vadodara, 390022

Other trials in India

Thailand3 sites

  • Research Site

    Bang Kra So, 11000

  • Research Site

    Bangkok, 10330

  • Research Site

    Hat Yai, 90110

Other trials in Thailand

Canada2 sites

  • Research Site

    Ajax, Ontario, L1S 2J5

  • Research Site

    Québec, Quebec, G1V4G5

Other trials in Canada

Peru1 site

  • Research Site

    Lima, 15046

Other trials in Peru

About this study

Official 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)

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

Read the detailed description

This is a multicentre, randomised, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma treated with maintenance OCS in combination with high dose inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA), with or without other asthma controller therapies. Approximately 207 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection using the accessorized pre-filled syringe (APFS), over a 28-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Conditions
Asthma
Being tested
Tezepelumab, Placebo
Keywords
Asthma, Severe Asthma, Oral Corticosteroid Dependent Asthma, Tezepelumab, Phase 3 Study, Reducing Oral Corticosteroid
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TezepelumabBiological

    Tezepelumab subcutaneous injection

  • PlaceboOther

    Placebo subcutaneous injection

Study groups in NCT05398263
Study groupRoleWhat they receive
TezepelumabExperimentalTezepelumab subcutaneous injection, in an accessorised pre-filled syringe.
Receives: Biological: Tezepelumab
PlaceboPlacebo comparatorPlacebo subcutaneous injection, in an accessorised pre-filled syringe.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control.

    Proportion of subjects by 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.

    Measured: Baseline to Week 28

Secondary outcomes (15)

  1. Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 28

    Change from baseline in pre-BD FEV1 at Week 28. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

    Measured: Baseline to Week 28

  2. Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 28

    Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%.

    Measured: Baseline to Week 28

  3. Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 28

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

    Measured: Week 28

  4. Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 28

    Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%.

    Measured: Baseline to Week 28

  5. Annualised Asthma Exacerbation Rate (AAER) Over 28 Weeks

    The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 28 weeks.

    Measured: Baseline to Week 28

  6. Proportion of Subjects With >= 1 Asthma Exacerbation

    Time to first asthma exacerbation, presented as proportion of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF

    Measured: Baseline to Week 28

  7. Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 28

    Change from baseline in ACQ-6 as compared to placebo at Week 28. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.

    Measured: Baseline to Week 28

  8. Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 28

    Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) as compared to placebo at Week 28. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly.

    Measured: Baseline to Week 28

  9. Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score at Week 28

    Change from baseline in AQLQ(S)+12 as compared to placebo at Week 28. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).

    Measured: Baseline to Week 28

  10. Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28

    Change from baseline in SGRQ as compared to placebo at Week 28. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.

    Measured: Baseline to Week 28

  11. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 28

    Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28.

    Measured: Baseline to Week 28

  12. Change From Baseline in Peripheral Blood Eosinophils at Week 28

    Change from baseline in blood eosinophil counts at Week 28.

    Measured: Baseline to Week 28

  13. Change From Baseline in Total Serum Immunoglobulin E (IgE) at Week 28

    Change from baseline in total serum IgE at Week 28.

    Measured: Baseline to Week 28

  14. PK: Serum Trough Concentrations at Week 0, 12 and 28

    Pharmacokinetics samples are collected at baseline and at Week 12 prior to study intervention administration, and at Week 28 (End of Treatment visit).

    Measured: Baseline, Week 12 and Week 28

  15. Immunogenicity: Incidence of Anti-drug Antibodies (ADA) at Week 0, 12, 28, and 40

    Immunogenicity samples are collected at baseline and at Week 12 prior to study intervention administration, at Week 28 (End of Treatment visit) and at Week 40 (Follow-up visit). Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.

    Measured: Baseline to Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start9 Aug 2022
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized in a 2:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398263
Sponsor's protocol ID
D5180C00024
Other IDs
05398263, 2023-504648-33, 2023-504648-33-00, 2021-006691-17, 2023
Acronym
SUNRISE
Status last verified
Jun 2026
First submitted
26 May 2022
Last updated
18 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Wechsler ME, Brightling CE, Brusselle G, Caminati M, Soler T, Gonzalez EM, Nakwan N, Capala-Szczurko I, Hunter G, Almqvist G, Lal H, Kabelis P, Scrigner P, Matsunaga Y, Molfino N, Ponnarambil SS; SUNRISE study investigators. Efficacy and safety of tezepelumab versus placebo in reducing oral corticosteroid use in adults with severe, oral corticosteroid-dependent asthma (SUNRISE): a multicentre, placebo-controlled, double-blind, phase 3 trial. Lancet Respir Med. 2026 Jun;14(6):481-492. doi: 10.1016/S2213-2600(26)00076-7. Epub 2026 May 18.

    PubMed 42150582

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tezepelumab in people with Asthma, run by AstraZeneca at 64 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Poland, Brazil, Chile, Mexico and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control. (time frame: Baseline to Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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