AzTrials
AzTrials

Severe AsthmaPhase 3ARRIVALNCT06473779

Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.

A Phase 3 study testing Tezepelumab, Budesonide/formoterol and Albuterol/budesonide (AIRSUPRA®) in people with Severe Asthma, run by AstraZeneca at 70 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma.. Study details include: 1. The study duration will be up to 72 weeks. 2. Read more about this study

Who is it for?
Ages 12 to 80 years
Conditions the study is for
Severe Asthma
What is being tested?
Tezepelumab, Budesonide/formoterol and Albuterol/budesonide (AIRSUPRA®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
70 sitesin 12 countries
Study dates
30 Sep 2024to 25 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Informed Consent
  • Provision of signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses for patients who are at or over the age of majority (as per local law). For patients who are less than the age of majority, in addition to providing their informed consent, the patients' legally authorised representative must also provide their informed assent (Appendix A 3).
  • Age
  • Patients must be 12 to 80 years of age inclusive, at the time of signing the ICF.
  • Type of Patient and Disease Characteristics
  • Documented medical record history for at least 12 months prior to Visit 1.
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  • Documented physician-diagnosed severe asthma within 10 years prior to Visit 1 (ie, severe asthma was not diagnosed more than 10 years prior) consisting of any of the following:
  • FEV1 > 12% reversibility, OR
  • Evidence of airflow variability (to show that lung function is altered over time): FEV1 ≥ 400 mL variability over time, OR
  • Challenge tests that are positive on one of the below:
  • Methacholine - PD20 ≤ 8 mg/mL (ii) Mannitol - PD15 15% drop on FEV1 out of dose < than 635 mg of inhaled mannitol (iii) Exercise - 10% fall of FEV1
  • ACQ-5 ≥ 1.5 and < 3.
  • History of physician-diagnosed asthma that requires continuous treatment with high-dose ICS (as defined by GINA or highest approved dose per posology per country) plus a LABA for at least 6 months prior to Visit 1 (Appendix I). The ICS and LABA can be contained within a combination product or given by separate inhalers.
  • Note: Additional maintenance asthma controller medications (eg, LTRAs, tiotropium, cromone, theophylline) are allowed.
  • Pre-brochodilator FEV1 > 60% predicted and evidence of FEV1 reversibility of > 12% within 6 months prior to screening or at screening. Patients with normal lung function (FEV1 > 80%) need evidence of airflow variability as per inclusion criterion 4.
  • Documented history of at least one asthma exacerbation requiring OCS bursts or requiring hospitalization within 12 months prior to Visit 1. An asthma exacerbation will be defined as a worsening of asthma symptoms that leads to any of the following:
  • A temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day bolus/burst of systemic corticosteroids
  • Or, an ER visit (defined as evaluation and treatment for < 24 hours in ER) due to asthma that required systemic corticosteroids (as per above)
  • Or, an in-patient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours).
  • Sex and Contraceptive/Barrier Requirements
  • Male or female.
  • Female patients:
  • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of nonchildbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the induction phase without an alternative medical cause.
  • The following age-specific requirements apply:
  • Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range.
  • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
  • Adolescents: if patient is female and has reached menarche or has reached Tanner stage 3 breast development (even if not having reached menarche), the patient will be considered a WOCBP.
  • WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:
  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP patient and that the vasectomised partner has received medical assessment of the surgical success)
  • Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.
  • Cessation of contraception after this point should be discussed with a responsible physician
  • Inclusion Criteria 5.1.2 Treatment Induction Phase at Visit 2 (Week 0):
  • Before dosing with tezepelumab at Week 0, patients should fulfil the following criteria:
  • ACQ-5 ≥ 1.5 and < 3.
  • Demonstrated proper inhaler technique (patients with improper technique at screening may be trained during screening, but must demonstrate proper technique before enrollment).
  • No excessive SABA use (should be < 5 puffs/day) or for patients using SMART therapy outside the US, no excessive use of SYMBICORT (should be ≤ 8 inhalations/day) or for US patients, no excessive use of AIRSUPRA (should be ≤ 12 inhalations/day).

Who cannot join

  • Medical Conditions
  • Any clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral EOS counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
  • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
  • Affect the safety of the patient throughout the study
  • Influence the findings of the study or the interpretation
  • Impede the patient's ability to complete the entire duration of study.
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  • 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 patients with smoking history ≥ 10 pack-years and patients 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.
  • History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
  • Tuberculosis requiring treatment within the 12 months prior to Visit 1.
  • History of known immunodeficiency disorder including a positive human immunodeficiency virus test at Visit 1, or the patient taking antiretroviral medications as determined by medical history and/or patient's verbal report.
  • Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia or inpatient status for > 1 day during the conduct of the study.
  • Evidence of COVID-19 within 4 weeks prior to screening or ongoing clinically significant COVID-19 sequelae.
  • Prior/Concomitant Therapy
  • 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 nonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1.
  • OCS-dependent patients (received chronic OCS therapy [prednisone ≥ 5 mg/day or equivalent]) for at least 3 months preceding Visit 1.
  • Daily use of maintenance corticosteroids for any reason.
  • Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
  • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
  • Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and during the study.
  • Patients that have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1.
  • Prior/Concurrent Clinical Study Experience
  • Known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
  • History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.
  • Concurrent enrolment in another clinical study involving an IMP.
  • Diagnostic Assessments
  • Any clinically meaningful abnormal finding in physical examination, haematology, clinical chemistry at Visit 1 which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete the entire duration of the study.
  • Evidence of active liver disease, including jaundice or AST, ALT, or ALP > 2 times the ULN at Visit 1.
  • Positive hepatitis B surface antigen, hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without a history of hepatitis B are allowed to participate.
  • Other Exclusions
  • Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or patients employed by or relatives of the employees of the site or AstraZeneca.
  • Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • For women only: Pregnant, breastfeeding, or lactating women. A serum β-HCG pregnancy test must be drawn for WOCBP at the screening visit. If the results of the serum β-HCG cannot be obtained prior to dosing of the IMP, a patient may be enrolled on the basis of a negative urine pregnancy test, though serum β-HCG must still be obtained. If either test is positive, the patient should be excluded. Since urine and serum tests may miss a pregnancy in the first days after conception, relevant menstrual history and sexual history, including methods of contraception, should be considered. Any patient whose menstrual and/or sexual history suggests the possibility of early pregnancy should be excluded.

Trial locations and contacts

70 sites in 12 countries.

70 sites in 12 countries

Argentina10 sites

  • Research Site

    Berazategui, 1104

  • Research Site

    CABA, C1012AAR

  • Research Site

    Concepción del Uruguay, 3260

  • Research Site

    Mendoza, 5500

  • Research Site

    Mendoza, M5500CCG

  • Research Site

    Quilmes, B1878FNR

  • Research Site

    Rosario, 2000

  • Research Site

    Rosario, 2002

  • Research Site

    San Miguel de Tucumán, 4000

  • Research Site

    Santa Fe, 3000

Other trials in Argentina

United States8 sites

  • Research Site

    Boston, Massachusetts, 02115

  • Research Site

    Colorado Springs, Colorado, 80907

  • Research Site

    McAllen, Texas, 78503

  • Research Site

    Miami, Florida, 33136

  • Research Site

    New Brunswick, New Jersey, 08901

  • Research Site

    Oklahoma City, Oklahoma, 73120

  • Research Site

    Palmdale, California, 93551

  • Research Site

    St Louis, Missouri, 63110

Other trials in United States

Bulgaria8 sites

  • Research Site

    Haskovo, 6300

  • Research Site

    Pleven, 5804

  • Research Site

    Razgrad, 7200

  • Research Site

    Rousse, 7002

  • Research Site

    Sofia, 1154

  • Research Site

    Sofia, 1431

  • Research Site

    Stara Zagora, 6003

  • Research Site

    Velika Tarnovo, 5250

Other trials in Bulgaria

Canada6 sites

  • Research Site

    Ajax, Ontario, L1S 2J5

  • Research Site

    Québec, Quebec, G1V 4G5

  • Research Site

    Regina, Saskatchewan, S7N 5A2

  • Research Site

    Sherbrooke, Quebec, J1H 5N4

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

  • Research Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

France6 sites

  • Research Site

    Créteil, 94000

  • Research Site

    La Tronche, 38700

  • Research Site

    Lyon, 69004

  • Research Site

    Marseille, 13915

  • Research Site

    Montpellier, 34295

  • Research Site

    Strasbourg, 67091

Other trials in France

Spain6 sites

  • Research Site

    Badalona(Barcelona), 08916

  • Research Site

    Barcelona, 08035

  • Research Site

    Lugo, 27002

  • Research Site

    Madrid, 28006

  • Research Site

    Madrid, 28040

  • Research Site

    Madrid, 28041

Other trials in Spain

Belgium5 sites

  • Research Site

    Anderlecht, 1070

  • Research Site

    Edegem, 2650

  • Research Site

    Erpent, 5101

  • Research Site

    Ghent, 9000

  • Research Site

    Liège, 4000

Other trials in Belgium

Germany5 sites

  • Research Site

    Augsburg, 86150

  • Research Site

    Bonn, 53127

  • Research Site

    Cottbus, 03050

  • Research Site

    Hanover, 30625

  • Research Site

    Mainz, 55128

Other trials in Germany

Italy5 sites

  • Research Site

    Florence, 50134

  • Research Site

    Orbassano, 10043

  • Research Site

    Roma, 00161

  • Research Site

    Roma, 00168

  • Research Site

    Verona, 37134

Other trials in Italy

Denmark4 sites

  • Research Site

    Aalborg, 9000

  • Research Site

    Hvidovre, 2650

  • Research Site

    Svendborg, 5700

  • Research Site

    Vejle, 7100

Other trials in Denmark

United Kingdom4 sites

  • Research Site

    Belfast, BT9 7BL

  • Research Site

    Liverpool, L7 8XP

  • Research Site

    London, SE1 9RT

  • Research Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Mexico3 sites

  • Research Site

    Chihuahua City, 31200

  • Research Site

    Cuauhtémoc, 06700

  • Research Site

    Monterrey, 64360

Other trials in Mexico

About this study

Official title: A Multicentre, Randomised, Open-Label, Parallel-Group, Phase IIIb Study to Assess the Potential for Tezepelumab-treated Patients With Severe Asthma to Reduce Background Therapy While Sustaining Asthma Control and Clinical Remission

The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma..

Study details include:

  1. The study duration will be up to 72 weeks.
  2. The treatment duration will be up to 68 weeks.
  3. The visit frequency will be once every 4 weeks (Q4W).
Read the detailed description

This is a multicentre, randomised, open-label, parallel-group, phase IIIb study to assess the potential for tezepelumab-treated patients to (1) reduce maintenance therapy without the loss of asthma control at Week 56, among those who demonstrated asthma control or low biomarkers at Week 24, and (2) be in asthma control and have characteristics of clinical remission at Week 24.

Approximately 65 sites in 10 countries will enrol adult and adolescent patients with severe uncontrolled asthma.

The study is divided into 5 phases as described below:

  • Screening/Run-in Phase (from Week -4 until Week 0, up to 4 Weeks)
  • Treatment Induction Phase (Week 0 to Week 4)
  • Treatment Continuation Phase (Week 4 to Week 24)
  • Tezepelumab Treatment With or Without ICS Step-down Therapy Phase (Week 24 to Week 56)
  • Maintenance Phase (Week 56 to Week 72)
Conditions
Severe Asthma
Being tested
Tezepelumab, Budesonide/formoterol, Albuterol/budesonide (AIRSUPRA®), Mannitol, Salbutamol
Keywords
Severe Asthma, ICS reduction, Asthma control, Clinical remission
Medical subject headings
Asthma

What participants receive

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

  • TezepelumabCombination product

    Also called TEZSPIRE®

    IMP. Subcutaneous injection. Unit dose strengths 210 mg.

  • Budesonide/formoterolCombination product

    Also called SYMBICORT® pMDI

    AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation

  • Albuterol/budesonide (AIRSUPRA®)Combination product

    Also called AIRSUPRA®

    AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only.

  • MannitolCombination product

    Also called ARIDOL®

    NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules

  • SalbutamolCombination product

    Also called Sabumalin, albuterol, ventolin HFA, Proair HFA, Proventil HFA

    AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation

Study groups in NCT06473779
Study groupRoleWhat they receive
Group 1 - Asthma Control or Low Biomarkers - Step-down of ICSExperimentalAsthma Control or Low Biomarkers - Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2
Receives: Combination Product: Tezepelumab; Combination Product: Budesonide/formoterol; Combination Product: Albuterol/budesonide (AIRSUPRA®); Combination Product: Mannitol; Combination Product: Salbutamol
Group 2 - Asthma Control or Low Biomarkers - No Step-down of ICSExperimentalAsthma Control or Low Biomarkers - No Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2
Receives: Combination Product: Tezepelumab; Combination Product: Budesonide/formoterol; Combination Product: Albuterol/budesonide (AIRSUPRA®); Combination Product: Mannitol; Combination Product: Salbutamol
Group 3 - No Asthma Control or Low Biomarkers - No Step-down of ICSExperimentalNo Asthma Control or Low Biomarkers - No Step-down of ICS
Receives: Combination Product: Tezepelumab; Combination Product: Budesonide/formoterol; Combination Product: Albuterol/budesonide (AIRSUPRA®); Combination Product: Mannitol

What is being measured

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

  1. Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase.

    Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase to either:

    Outside of the US:

    • Medium-dose maintenance and reliever therapy, or
    • Low-dose maintenance and reliever therapy, or
    • SYMBICORT® anti-inflammatory reliever only

    In the US:

    • Medium-dose SYMBICORT® and AIRSUPRA®,or
    • Low-dose SYMBICORT® and AIRSUPRA®, or
    • AIRSUPRA® only

    Measured: Week 56

Secondary outcomes (41)

  1. Proportion of patients in asthma control

    Proportion of patients in asthma control at Week24.

    Measured: Week 24

  2. Proportion of patients with characteristics of clinical remission

    Proportion of patients with characteristics of clinical remission at Week 24

    Measured: Week 24

  3. Proportion of patients in asthma control at Week 56 among those in asthma control at Week 24

    Proportion of patients in asthma control at Week 56 among those in asthma control at Week 24; summarised separately for patients randomised to ICS step-down and for patients randomised to no step-down of ICS.

    Measured: Week 56

  4. Proportion of patients in asthma control at Week 72 among those in asthma control at Week 24

    Proportion of patients in asthma control at Week 72 among those in asthma control at Week 24; summarised separately for patients randomised to ICS step-down and for patients randomised to no step-down of ICS.

    Measured: Week 72

  5. Proportion of patients in asthma control at both Week 56 and Week 72 among those in asthma control at Week 24

    Proportion of patients in asthma control at both Week 56 and Week 72 among those in asthma control at Week 24; summarised separately for patients randomised to ICS step-down and for patients randomised to no step-down of ICS.

    Measured: Week 56 and Week 72

  6. Proportion of patients in asthma control at Week 56 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Proportion of patients in asthma control at Week 56 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Measured: Week 56

  7. Proportion of patients in asthma control at Week 72 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Proportion of patients in asthma control at Week 72 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Measured: Week 72

  8. Proportion of patients in clinical remission at Week 56 among those with characteristics of clinical remission at Week 24

    Proportion of patients in clinical remission at Week 56 among those with characteristics of clinical remission at Week 24; summarised separately for patients randomised to ICS step-down and for patients randomised to no step-down of ICS.

    Measured: Week 56

  9. Proportion of patients in clinical remission at Week 72 among those with characteristics of clinical remission at Week 24

    Proportion of patients in clinical remission at Week 72 among those with characteristics of clinical remission at Week 24; summarised separately for patients randomised to ICS step-down and for patients randomised to no step-down of ICS.

    Measured: Week 72

  10. Proportion of patients in clinical remission at both Week 56 and Week 72 among those with characteristics of clinical remission at Week 24

    Proportion of patients in clinical remission at both Week 56 and Week 72 among those with characteristics of clinical remission at Week 24; summarised separately for patients randomised to ICS step-down and for patients randomised to no step-down of ICS.

    Measured: Week 56 and Week 72

  11. Proportion of patients in clinical remission at Week 56 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Proportion of patients in clinical remission at Week 56 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Measured: Week 56

  12. Proportion of patients in clinical remission at Week 72 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Proportion of patients in clinical remission at Week 72 among those who demonstrated neither asthma control nor low biomarkers at Week 24

    Measured: Week 72

  13. Proportion of patients in complete remission at Week 56

    Proportion of patients in complete remission at Week 56; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Week 56

  14. Proportion of patients in complete remission at Week 72 among those in complete remission at Week 56

    Proportion of patients in complete remission at Week 72 among those in complete remission at Week 56; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Week 72

  15. Change from Week 24 at Week 56 in: ° Mean monthly maintenance ICS dose ° Mean monthly rescue ICS dose ° Mean monthly total ICS dose (maintenance and rescue doses)

    Change from Week 24 at Week 56 in:

    • Mean monthly maintenance ICS dose
    • Mean monthly rescue ICS dose
    • Mean monthly total ICS dose (maintenance and rescue doses)

    Measured: From Week 24 at Week 56

  16. Change from Week 24 at Week 72 in: ° Mean monthly maintenance ICS dose ° Mean monthly rescue ICS dose ° Mean monthly total ICS dose (maintenance and rescue doses)

    Change from Week 24 at Week 72 in:

    • Mean monthly maintenance ICS dose
    • Mean monthly rescue ICS dose
    • Mean monthly total ICS dose (maintenance and rescue doses)

    Measured: From Week 24 at Week 72

  17. Cumulative daily ICS dose (maintenance and rescue doses) between Week 24 and Week 56

    Cumulative daily ICS dose (maintenance and rescue doses) between Week 24 and Week 56 both summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Between Week 24 and Week 56

  18. Cumulative daily ICS dose (maintenance and rescue doses) between Week 56 and Week 72

    Cumulative daily ICS dose (maintenance and rescue doses) between Week 56 and Week 72 both summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Between Week 56 and Week 72

  19. Cumulative daily ICS dose (maintenance and rescue doses) between Week 24 and Week 72

    Cumulative daily ICS dose (maintenance and rescue doses) between Week 24 and Week 72 both summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Between Week 24 and Week 72

  20. AAER between Week 0 and Week 24 among all tezepelumab-treated patients

    Annualised Asthma Exacerbation Rate between Week 0 and Week 24 among all tezepelumab-treated patients.

    Measured: Between Week 0 and Week 24

  21. AAER between Week 24 and Week 56

    Annualised Asthma Exacerbation Rate between Week 24 and Week 56 summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Between Week 24 and Week 56

  22. AAER between Week 56 and Week 72

    Annualised Asthma Exacerbation Rate between Week 56 and Week 72 summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Between Week 56 and Week 72

  23. AAER between Week 24 and Week 72

    Annualised Asthma Exacerbation Rate between Week 24 and Week 72 summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Between Week 24 and Week 72

  24. ACQ-5 score and changes from baseline at Week 24 among all tezepelumab-treated patients

    ACQ-5 score and changes from baseline at Week 24 among all tezepelumab-treated patients

    Measured: From baseline at Week 24

  25. ACQ-5 score and changes from Week 24 at Week 56

    ACQ-5 score and changes from Week 24 at Week 56; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 56

  26. ACQ-5 score and changes from Week 24 at Week 72

    ACQ-5 score and changes from Week 24 at Week 72; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 72

  27. Proportion of ACQ-5 responders (improvement of≥ 0.5 in ACQ-5 score) from baseline at Week 24 among all tezepelumab-treated patients.

    Proportion of ACQ-5 responders (improvement of≥ 0.5 in ACQ-5 score) from baseline at Week 24 among all tezepelumab-treated patients.

    Measured: From baseline at Week 24

  28. Proportion of ACQ-5 responders (improvement of≥ 0.5 in ACQ-5 score) from Week 24 at Week 56

    Proportion of ACQ-5 responders (improvement of≥ 0.5 in ACQ-5 score) from Week 24 at Week 56; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 56

  29. Proportion of ACQ-5 responders (improvement of≥ 0.5 in ACQ-5 score) from Week 24 at Week 72

    Proportion of ACQ-5 responders (improvement of≥ 0.5 in ACQ-5 score) from Week 24 at Week 72; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 72

  30. SGRQ total score and changes from baseline at Week 24 among all tezepelumab-treated patients.

    SGRQ total score and changes from baseline at Week 24 among all tezepelumab-treated patients.

    Measured: From baseline at Week 24

  31. SGRQ total score and changes from Week 24 at Week 56

    SGRQ total score and changes from Week 24 at Week 56, summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 56

  32. SGRQ total score and changes from Week 24 at Week 72

    SGRQ total score and changes from Week 24 at Week 72, summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 72

  33. Proportion of SGRQ responders (improvement of≥ 4 in SGRQ total score) from baseline at Week 24 among all tezepelumab-treated patients.

    Proportion of SGRQ responders (improvement of≥ 4 in SGRQ total score) from baseline at Week 24 among all tezepelumab-treated patients

    Measured: From baseline at Week 24

  34. Proportion of SGRQ responders (improvement of≥ 4 in SGRQ total score) from Week 24 at Week 56

    Proportion of SGRQ responders (improvement of≥ 4 in SGRQ total score) from Week 24 at Week 56; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 56

  35. Proportion of SGRQ responders (improvement of≥ 4 in SGRQ total score) from Week 24 at Week 72

    Proportion of SGRQ responders (improvement of≥ 4 in SGRQ total score) from Week 24 at Week 72; summarised separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: From Week 24 at Week 72

  36. Pre-BD FEV1 actual values and changes from baseline at Week 24 among all tezepelumab-treated patients.

    Asthma exacerbations, patient-reported outcomes, and lung function. Pre-BD FEV1 actual values and changes from baseline at Week 24 among all tezepelumab-treated patients.

    Measured: Baseline at Week 24

  37. Pre-BD FEV1 total score and changes from Week 24 at Week 56

    Pre-BD FEV1 total score and changes from Week 24 at Week 56, summarized separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24 among all tezepelumab-treated patients.

    Measured: From Week 24 at Week 56

  38. Pre-BD FEV1 total score and changes from Week 24 at Week 72

    Pre-BD FEV1 total score and changes from Week 24 at Week 72, summarized separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24 among all tezepelumab-treated patients.

    Measured: From Week 24 at Week 72

  39. Proportion of pre-BD FEV1 responders from baseline at Week 24

    Proportion of pre-BD FEV1 responders from baseline (defined as patients who achieve either a≥ 5% or ≥ 100 mL improvement from baseline) at Week 24, for all tezepelumab-treated patients

    Measured: Week 24

  40. Proportion of pre-BD FEV1 responders at Week 56 among those who were pre-BDFEV1 responders at Week 24

    Proportion of pre-BD FEV1 responders at Week 56 among those who were pre-BDFEV1 responders at Week 24; summarized separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Week 56

  41. Proportion of pre-BD FEV1 responders at Week 72 among those who were pre-BDFEV1 responders at Week 24

    . Proportion of pre-BD FEV1 responders at Week 72 among those who were pre-BDFEV1 responders at Week 24; summarized separately for patients randomised to ICS step-down, randomised to no ICS step-down, and those who demonstrated neither asthma control nor low biomarkers at Week 24.

    Measured: Week 72

Timeline

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

  1. First posted25 Jun 2024
  2. Study start30 Sep 2024
  3. Primary completion25 Jun 2027 (estimated)
  4. Study completion25 Jun 2027 (estimated)

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
Open-Label, Parallel-Group treatment study with 3 arms. Participants will be treated with tezepelumab Q4W from Week 0, with the last dose administered at Week 68
Masking
None (open label)
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473779
Sponsor's protocol ID
D5180C00047
Acronym
ARRIVAL
Status last verified
Oct 2026
First submitted
10 Jun 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
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 Vivli.org. All requests will be evaluated as 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 approved.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tezepelumab, Budesonide/formoterol and Albuterol/budesonide (AIRSUPRA®) in people with Severe Asthma, run by AstraZeneca at 70 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?

The sponsor lists 41 inclusion and 33 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in Argentina, United States, Bulgaria, Canada, France 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. 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?

This study is still under way. Results are not available in the source record yet.

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 patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase. (time frame: Week 56). 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 NCT06473779.

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 13 Oct 2026.

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