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    Summary
    EudraCT Number:2026-000081-25
    Sponsor's Protocol Code Number:D5180C00032
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-03-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2026-000081-25
    A.3Full title of the trial
    A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants with Severe Asthma including Several Under-Studied populations in the United States
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single-arm, open-label, Phase 4 effectiveness and safety study of tezepelumab in adults and adolescent participants with severe asthma in the United States
    A.3.2Name or abbreviated title of the trial where available
    PASSAGE
    A.4.1Sponsor's protocol code numberD5180C00032
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05329194
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tezspire-APFS
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTezepelumab
    D.3.2Product code MEDI9929
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG157
    D.3.9.4EV Substance CodeSUB179650
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe asthma exacerbations in the 12-month periods
    before (baseline period) and after initiation of tezepelumab
    (study period)
    E.2.2Secondary objectives of the trial
    - To describe the time to first exacerbation after initiation of
    tezepelumab
    - To describe asthma exacerbations resulting in
    hospitalizations, emergency department/urgent care visits in
    the 12-month periods before - baseline period (BP) and after
    initiation of Tezepelumab – study period (SP)
    - To describe lung function at baseline and months 6 and 12
    after initiation of tezepelumab
    - To describe Asthma Control Questionnaire (ACQ-6), Asthma
    Impairment and Risk Questionnaire (AIRQ), and St. George’s
    Respiratory Questionnaire (SGRQ) at baseline and months 6
    and 12 after initiation of tezepelumab
    - To describe systemic corticosteroid (SCS) use in the 12-
    month periods before (baseline period) and after initiation of
    tezepelumab (study period)
    - To describe asthma-related healthcare resource utilization
    (HRU) in the 12-month periods before (baseline period) and
    after initiation of tezepelumab (study period)
    - For other secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1, Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
    2, Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
    3, Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment.
    4, Use of additional asthma maintenance controller
    medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)).
    5, Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
    6, Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
    7, Currently receiving care from specialist physicians (eg,pulmonologists and/or allergists).
    8, Provision of signed and dated written informed consent form
    E.4Principal exclusion criteria
    1, Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
    2, Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines
    (GOLD 2021).
    3, Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer)
    prior to enrollment.
    4, Participation in an interventional clinical trial for asthma within 12 months prior to enrollment.
    5, Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized asthma exacerbation rate (AAER) over 52 weeks before (baseline period) and after initiation of tezepelumab (study period)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline period up to study Week 52
    E.5.2Secondary end point(s)
    - Time to first asthma exacerbation
    - Rate of asthma exacerbations associated with
    hospitalizations
    - Rate of asthma exacerbations associated with ED/UC visits
    - Rate of asthma exacerbations associated with
    hospitalizations or ED/UC visits
    - Proportion of participants with asthma exacerbations
    associated with hospitalizations or ED/UC visits
    - Cumulative asthma exacerbations associated with
    hospitalizations or ED/UC visits
    - Pre-bronchodilator (pre-BD) forced expiratory volume in 1
    second (FEV1)
    - Change from baseline in pre-bronchodilator FEV1
    - Proportion of pre-BD FEV1 responders
    - Change from baseline in Asthma Control Questionnaire
    (ACQ-6) score
    - Change from baseline in Asthma Impairment and Risk
    Questionnaire (AIRQ) score
    - Change from baseline in St. George's Respiratory
    Questionnaire (SGRQ) score
    - Proportion of ACQ-6 responders
    - Proportion of AIRQ responders
    - Proportion of SGRQ responders
    - Proportion of participants who require any systemic
    corticosteroid (SCS) use
    - Cumulative annualized SCS dose
    - Proportion of participants who require longer-term (>30 consecutive days) SCS use
    - Number and type of asthma-related healthcare resource utilization (HRU)
    - Duration of asthma-related hospitalizations
    - AAER for asthma exacerbations (subgroups of participants)
    - Proportion of participants with asthma exacerbations
    (subgroups of participants)
    - Proportion of participants who completed the 52 week study with any reduction in total number of asthma exacerbations (subgroups of participants)
    - Cumulative asthma exacerbation days (subgroups of
    participants)
    - Rate of asthma exacerbations associated with
    hospitalizations (subgroups of participants)
    - Rate of asthma exacerbations associated with emergency department urgent care (ED/UC) visits (subgroups of participants)
    - Rate of asthma exacerbations associated with
    hospitalizations or ED/UC visits over (subgroups of
    participants)
    - Number and type of asthma-related HRU (subgroups of participants)
    - Duration of asthma-related hospitalizations (subgroups of participants)
    - Supportive endpoints to the primary endpoint:
    * Proportion of participants with asthma exacerbations
    * Proportion of participants who completed the 52-week
    study period
    * Cumulative asthma exacerbation days over 52 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline period up to study Week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of the last
    scheduled procedure for the last participant in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 19
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 19
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 77
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2026-03-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants who complete Visit 15 should be given standard of care, which may include commercially available tezepelumab, at the discretion of the Investigator. Tezepelumab will not be available via the study following the end of the Treatment Period.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Parexel International
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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