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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43724   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2018-002501-53
    Sponsor's Protocol Code Number:D5180C00018
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002501-53
    A.3Full title of the trial
    A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel
    Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability
    of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
    Wieloośrodkowe, randomizowane, prowadzone w grupach równoległych z zastosowaniem metodyki podwójnie ślepej próby, kontrolowane placebo, przedłużone badanie fazy III, oceniające bezpieczeństwo i tolerancję tezepelumabu u pacjentów dorosłych i niepełnoletnich z rozpoznaniem ciężkiej, źle kontrolowanej astmy oskrzelowej (DESTINATION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 extension study designed to evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with severe, uncontrolled asthma on Inhaled Corticosteroids and at least one additional asthma controller
    Przedłużone badanie fazy III oceniające bezpieceństwo i tolerancję texepelumabu u pacjentów dorosłych i niepełnoletnich z rozpoznaniem ciężkiej, źle kontrolowanej astmy oskrzelowej przyjmujących wziewne kortykosteroidy w połączeniu z co najmniej jednym dodatkowym lekiem kontrolującym objawy astmy.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD5180C00018
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/316/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    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.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    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 No
    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 anti-TSLP mAb (AMG157)
    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 nameAMG 157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number99 to 121
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 Yes
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Uncontrolled Asthma
    Ciężka, źle kontrolowana astma
    E.1.1.1Medical condition in easily understood language
    Severe Asthma
    Ciężka astma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of
    Tezepelumab in severe asthma subjects
    Ocena długoterminowego bezpieczeństwa i tolerancji tezepelumabu u pacjentów z ciężką astmą
    E.2.2Secondary objectives of the trial
    To assess the long-term effect of 210 mg
    Tezepelumab SC Q4W on asthma exacerbations in
    adult and adolescent subjects with severe
    uncontrolled asthma compared with placebo
    Ocena długoterminowego wpływu tezepelumabu SC w dawce 210 mg podawanego co 4 tygodnie na zaostrzenia astmy u osób dorosłych i młodzieży z ciężką, żle kontrolowaną astmą w porównaniu z placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of signed and dated informed consent form prior to any mandatory study specific procedures, sampling and analysis.

    2) Negative urine pregnancy test for female subjects of childbearing potential prior to administration of IP at visit 1

    3) Subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either predecessor study D5180C00007 or D5180C00009

    To enter the extended follow-up phase of the study, the following
    inclusion criteria also apply:
    4) Provision of signed and dated addendum to informed consent, as well
    as assent by adolescent subjects where applicable, prior to any
    mandatory study specific procedures, sampling and analyses for
    Extended Follow Up.
    5) Subjects who rollover from D5180C00007 study and in DESTINATION
    have completed IP dosing to Week 100, have not met IP Discontinuation criteria and have attended the study EOT Visit.
    1. Podpisanie i opatrzenie datą pisemnego formularza świadomej zgody przed rozpoczęciem jakichkolwiek procedur związanych z badaniem, pobraniem jakichkolwiek próbek i wykonaniem jakichkolwiek analiz.
    2. Ujemny wynik testu ciążowego u kobiet zdolnych do posiadania potomstwa przed podaniem IP podczas wizyty 1.
    3. Kobiety lub mężczyźni, którzy nie spełnili kryteriów przerwania stosowania badanego produktu i w przypadku których odbyła się wizyta EOT w badaniu D5180C00007 lub D5180C00009.

    Następujące kryteria muszą zostać spełnione w celu włączenia do przedłużonego okresu obserwacji:
    4. Podpisnie i opatrzenie datą Dodatku do formularza świadomej zgody jak również zgody pacjenta pediatrycznego jeżeli dotyczy, przed rozpoczęciem jakichkolwiek procedur związanych z badaniem, pobraniem jakichkolwiek próbek i wykonaniem jakichkolwiek analiz na poczet przedłużonego okresu obserwacji.
    5. Pacjenci którzy przechodzą z badania D5180C00007 i w badaniu DESTINATIION zakończyli przyjmowanie leku badanego przed 100 tygodniem, nie spełnili kryterium wyłączenia z badania i odbyli wizytę kończącą udział w badaniu.
    E.4Principal exclusion criteria
    1) Any clinically important pulmonary disease other than asthma

    2) Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic,
    renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological,
    psychiatric, or major physical impairment that is not stable in the opinion of the

    3) Any history of chronic alcohol or drug abuse within 12 months prior to Visit 1

    4) Current malignancy or malignancy that developed during a predecessor study

    5) Treatment with the following medications within the last 12 weeks prior to
    randomization: Systemic immunosuppressive/immunomodulating drugs except for OCS used for the treatment of asthma

    6) Any important protocol deviations in either of the predecessor studies

    7) Pregnant, breastfeeding, or lactating women
    To enter the extended follow-up phase of the study, the following
    exclusion criteria also apply:
    8) Discontinuation of IP during the treatment period of DESTINATION.
    9) Entered DESTINATION from D5180C00009 (SOURCE) study.
    1. Jakakolwiek klinicznie istotna choroba płuc inna niż astma;
    2. Dowolne zaburzenie, w tym między innymi choroba układu krążenia, układu pokarmowego, wątroby, nerek, układu nerwowego, układu mięśniowo-szkieletowego, zakaźna, endokrynologiczna, metaboliczna, hematologiczna, psychiatryczna lub znacznego stopnia upośledzenie fizyczne, które w opinii Badacza nie jest stabilne;
    3. Długotrwałe nadużywanie alkoholu lub substancji psychoaktywnych w wywiadzie w okresie 12 miesięcy przed wizytą 1;
    4. Występujący aktualnie nowotwór złośliwy lub nowotwór złośliwy, który rozwinął się podczas wcześniejszego badania;
    5. Leczenie następującymi lekami w okresie ostatnich 12 tygodni przed randomizacją: podawane drogą ogólnoustrojową leki immunosupresyjne/immunomodulacyjne, z wyjątkiem kortykosteroidów doustnych stosowanych w leczeniu astmy/zaostrzeń astmy;
    6. Pacjenci z istotnymi odstępstwami od protokołu w jednym z wcześniejszych badań;
    7. Kobiety w ciąży, karmiące piersią, lub w okresie laktacji.
    W celu włączenia do przedłużonego okresu obserwacji obowiązują następujące kryteria wyłączenia:
    8. Zakończenie przyjmowania leczenia badanego w badaniu DESTINANTION
    9. Włączenie do badania DESTINATION z badania D5180C00009 (SOURCE)
    E.5 End points
    E.5.1Primary end point(s)
    Exposure adjusted rates of AEs/SAEs
    Skorygowana o ekspozycję częstość występowania AE/SAE
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Week 0 in predecessor study) to 104 weeks
    Wartość wyjściowa (określona w tygodniu 0 w ramach wcześniejszego badania) do 104 tygodni
    E.5.2Secondary end point(s)
    Annualized asthma exacerbation rate (AAER)
    Częstość występowania zaostrzeń astmy w skali roku (AAER)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (Week 0 in predecessor study) to 104 weeks
    Wartość wyjściowa (określona w tygodniu 0 w ramach wcześniejszego badania) do 104 tygodni
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Pacjenci, którzy zakończą leczenia z zastosowaniem IMP w badaniu D5180C00007 lub D5180C00009
    Patients who complete treatment period on IMP in D5180C00007 or D5180C00009
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    Russian Federation
    Saudi Arabia
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 65
    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. of subjects for this age range: 65
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 785
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 177
    F.4.2.2In the whole clinical trial 975
    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)
    Nie dotyczy
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-18
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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