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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    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 ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-005396-25
    Sponsor's Protocol Code Number:D3250C00037
    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:2016-05-12
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-005396-25
    A.3Full title of the trial
    A Multicenter, Open-label, Safety Extension Study with Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
    Wieloośrodkowe, prowadzone metodą próby otwartej, przedłużone badanie bezpieczeństwa stosowania benralizumabu (MEDI-563) u pacjentów dorosłych z rozpoznaniem astmy oskrzelowej, leczonych kortykosteroidem wziewnym w połączeniu z długo działającym antagonistą β2 (Badanie MELTEMI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety Extension Study with Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus LABA
    Przedłużone badanie bezpieczeństwa stosowania benralizumabu (MEDI-563) u pacjentów dorosłych z rozpoznaniem astmy oskrzelowej, leczonych kortykosteroidem wziewnym w połączeniu z długo działającym antagonistą β2
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD3250C00037
    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.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.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 pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen 9
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post code151 85
    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 namebenralizumab
    D.3.2Product code MEDI-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Asthma (an illness that causes breathing difficulty) that is not fully controlled,
    so that episodes of breathing difficulty are still occuring despite the use of
    other available treatments
    Astma (schorzenie powodujące trudności w oddychaniu), która nie jest w pełni kontrolowana, przez co nadal – mimo stosowania innych dostępnych leków – pojawiają się napady trudności w oddychaniu
    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 assess the safety and tolerability of 2 dosing regimens of benralizumab for adult patients
    Ocena bezpieczeństwa i tolerancji 2 schematów dawkowania benralizumabu u pacjentów dorosłych
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of 2 dosing regimens of benralizumab on asthma exacerbations, and asthma-related hospitalizations and emergency room visits
    • To evaluate the pharmacodynamics and immunogenicity of 2 dosing regimens of benralizumab for adult patients
    • Ocena wpływu 2 schematów dawkowania benralizumabu na zaostrzenia astmy oraz hospitalizacje i wizyty w izbie przyjęć / pogotowiu ratunkowym z powodu astmy
    • Ocena farmakodynamiki i immunogenności 2 schematów dawkowania benralizumabu u pacjentów dorosłych
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.2. Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.3.Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of IP. 4.For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1. 5.All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
    1.Udzielenie świadomej zgody pacjenta na udział w badaniu przed wykonaniem jakichkolwiek czynności i procedur związanych z badaniem, a także zgodnie z międzynarodowymi wytycznymi oraz/lub odnośnymi wytycznymi obowiązującymi
    w Unii Europejskiej.
    2.Kobiety i mężczyźni, którzy ukończyli co najmniej 16 i nie więcej niż 40 tygodni udziału w badaniu D3250C00021.
    3.Kobiety mogące zajść w ciążę (zdolne do posiadania potomstwa) muszą wyrazić zgodę na stosowanie wysoce efektywnej metody antykoncepcji w okresie całego udziału w badaniu oraz 16 tygodni od przyjęcia ostatniej dawki leku badanego.
    4.Kobiety mogące zajść w ciążę (zdolne do posiadania potomstwa): negatywny wynik paskowego testu ciążowego z moczu podczas wizyty 1, przed podaniem pierwszej dawki leku badanego.
    5.Wszyscy mężczyźni, którzy są aktywni seksualnie muszą wyrazić zgodę na użycie podwójnej barierowej metody antykoncepcji (prezerwatywa + środek plemnikobójczy) od przyjęcia pierwszej dawki, aż do 16 tygodni po ostatniej dawce leku badanego.
    E.4Principal exclusion criteria
    1. 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 Investigator and could:Affect the safety of the patient throughout the study; Influence the findings of the study or their interpretations; Impede the patient’s ability to complete the entire duration of study. 2. A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy. 3. Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study 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 interfere with the patient’s ability to complete the entire duration of the study. 4. Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded). 5.Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP. 6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1. 7. Planned major surgical procedures during the conduct of the study. 8. Previous participation in the present study. 9. Concurrent enrolment in another drug-related interventional clinical trial. 10. AstraZeneca staff involved in the planning and/or conduct of the study. 11. Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals. 12. Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor. 13. Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved (see Section
    1.Jakakolwiek niestabilna choroba w tym, ale nie ograniczając się do chorób układu
    sercowo – naczyniowego, układu pokarmowego, wątroby, nerek, układu nerwowego,
    układu mięśniowo – szkieletowego, chorób zakaźnych, endokrynologicznych,
    metabolicznych, hematologicznych, psychicznych lub poważne nieustabilizowane
    upośledzenie fizyczne, które w opinii badacza może:
    - mieć negatywny wpływ na bezpieczeństwo pacjenta w trakcie udziału w badaniu
    - zakłócić ocenę danych zebranych w czasie badania lub ich interpretację
    - ograniczać zdolność pacjenta do ukończenia badania.
    2.Jelitowe zakażenia pasożytnicze rozpoznane podczas badania poprzedzającego, które wymagało hospitalizacji lub nie było leczone lub nie zostało całkowicie wyleczone bądź też nie uzyskano odpowiedzi na leczenie standardowe.
    3.Wszelkie klinicznie istotne nieprawidłowości w badaniu fizykalnym, ocenie parametrów życiowych, EKG, badaniach laboratoryjnych hematologii, biochemii, badaniu moczu zdiagnozowane w trakcie badań poprzedzających, które w opinii badacza mogą zagrozić bezpieczeństwu pacjenta w trakcie udziału w badaniu, mogą mieć wpływ na uzyskane wyniki lub mogą ograniczać zdolność pacjenta do ukończenia badania.
    4.Obecnie rozpoznany nowotwór lub nowotwór zdiagnozowany w trakcie poprzedzającego badania (pacjenci ze zdiagnozowanym rakiem podstawno komórkowym, zlokalizowanym kolczysto komórkowym rakiem skóry leczonym operacyjnie metodą radykalną, lub rakiem szyjki macicy in situ, który został poddany leczeniu/został wyleczony, nie zostaną wyłączeni z badania).
    5.Otrzymywanie żywej atenuowanej szczepionki w ciągu 30 dni przed rozpoczęciem podawania leku badanego w tym badaniu, w okresie podawania leku oraz 16 tygodni po ostatniej dawce leku (5 okresów półtrwania).
    6.Stosowanie immunoglobuliny lub produktów krwiopochodnych w ciągu 30 dni przed wizytą 1.
    7.Zaplanowane w trakcie udziału w badaniu zabiegi chirurgiczne.
    8.Włączenie do tego badania w przeszłości.
    9.Aktualny udział w innym badaniu klinicznym.
    10.Pracownicy AstraZeneca zaangażowani w planowanie / przeprowadzenie badania.
    11.Pracownicy ośrodka prowadzącego badania i wszelkie inne osoby zaangażowane bezpośrednio w prowadzenie badania, oraz członkowie ich najbliższych rodzin.
    12.Pacjenci, w przypadku których doszło do wystąpienia istotnych odstępstw od protokołu badania w badaniu poprzedzającym, zależnie od decyzji Sponsora
    13.Pacjenci, u których aktualnie utrzymują się poważne zdarzenia niepożądane (SAEs)
    z badania poprzedzającego, nie powinni być włączani do udziału w tym przedłużonym badaniu do czasu ich ustąpienia (patrz rozdział
    E.5 End points
    E.5.1Primary end point(s)
    Number of Adverse Events/Serious Adverse Events (AEs/SAEs)
    Zdarzenia niepożądane / ciężkie zdarzenia niepożądane
    E.5.1.1Timepoint(s) of evaluation of this end point
    around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval
    około 108 tygodni, okres ten może się różnić w zależności od terminu uzyskania w danym kraju pozwolenia na dopuszczenie do obrotu
    E.5.2Secondary end point(s)
    • Asthma exacerbations
    • Asthma-related hospitalizations and emergency room visits.
    • Eosinophil levels
    • Anti-drug antibodies (ADA)
    • Zaostrzenia astmy
    • Hospitalizacje i wizyty na oddziale ratunkowym/izbie przyjęć z powodu astmy
    • Liczba eozynofili we krwi
    • Przeciwciała przeciwko lekowi
    E.5.2.1Timepoint(s) of evaluation of this end point
    around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval
    około 108 tygodni, okres ten może się różnić w zależności od terminu uzyskania w danym kraju pozwolenia na dopuszczenie do obrotu
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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 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 Yes
    E. description
    2 schematy dawkowania
    two dosing regiments
    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 concerned36
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Czech Republic
    Russian Federation
    South Africa
    United Kingdom
    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
    „LVLS” (Last Visit Last Subject)
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1100
    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 Decision2016-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-18
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