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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   43722   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:2021-000267-72
    Sponsor's Protocol Code Number:D3252C00002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-000267-72
    A.3Full title of the trial
    A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)
    Wieloośrodkowe, randomizowane, prowadzone metodą podwójnie ślepej próby w grupach równoległych, kontrolowane za pomocą placebo badanie fazy III oceniające skuteczność i bezpieczeństwo stosowania benralizumabu u pacjentów z eozynofilowym przewlekłym zapaleniem nosa i zatok z polipami nosa (ORCHID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of repeating dose of benralizumab administered SC versus placebo in patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps.
    Badanie oceniające skuteczność i bezpieczeństwo stosowania powtarzanych dawek benralizumabu podawanych podskórnie u pacjentów z eozynofilowym przewlekłym zapaleniem nosa i zatok z polipami nosa
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD3252C00002
    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 Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concorde Pike
    B.5.3.2Town/ cityWilmington, DE
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    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. name Fasenra
    D. of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.10 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Patient with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps
    Pacjenci z przewlekłym zapaleniem błony śluzowej nosa i zatok przynosowych z polipami nosa
    E.1.1.1Medical condition in easily understood language
    Chronic Rhinosinusitis with Nasal polyposis (CRSwNP) is a chronic inflammatory disease of the nasal mucosa characterized by the presence of polyps in the upper nasal cavity.
    Przewlekłe zapalenie błony śluzowej nosa i zatok przynosowych z polipami nosa (CRSwNP) to przewlekła choroba zapalna błony śluzowej nosa, z obecnością polipów w górnej części jamy nosowej
    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 evaluate the effect of benralizumab on nasal polyp burden (assessed by nasal endoscopy) and patient-reported nasal blockage (NB).
    Ocena wpływu stosowania benralizumabu na obciążenie polipami (ocenianego za pomocą endoskopii nosa) i niedrożność nosa (ang. nasal blockage, NB) w ocenie pacjenta
    E.2.2Secondary objectives of the trial
    To evaluate the effect of benralizumab on:
    • Sense of Smell
    • Sinus Opacification by computed tomography (CT) scan
    • Disease specific health-related quality of life (HRQoL)
    • Nasal polyp surgery
    • Systemic corticosteroid (SCS) use
    • Symptoms associated with CRSwNP
    Ocena wpływu benralizumabu na:
    1. Węch
    2. Utratę przejrzystości zatok w badaniu TK
    3. Zależną od choroby jakość życia uwarunkowaną stanem zdrowia (HRQoL)
    4. Operacje polipów nosa
    5. Stosowanie ogólnoustrojowych kortykosteroidów
    6. Objawy związane z CRSwNP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male patients aged 18 to 75 years inclusive
    2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
    3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
    4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
    5. Ongoing symptoms for at least 12 weeks prior to enrolment
    6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
    7. Bi-weekly mean NBS ≥ 1.5 at randomization
    8. SNOT-22 total score ≥ 20 at enrolment and randomization
    9. Documented physician-diagnosed asthma
    10. Blood eosinophil count of >2% or ≥150/μL at enrolment
    1. Pacjent musi być w wieku od 18 do 75 lat włącznie
    2. Leczenia kortykosteroidami donosowymi w stałych dawkach przez co najmniej 4 tygodnie przed włączeniem do badania i cały okres przesiewowy
    3. Stosowanie w przeszłości leczenia kortykosteroidami ogólnoustrojowymi (doustnymi) i/lub przebycie zabiegu chirurgicznego w związku z CRSwNP
    4. Pacjenci z obustronną polipowatością nosa i zatok przynosowych z wynikiem łącznej oceny NPS wynoszącym 5 punktów podczas włączenia do badania i randomizacji (wynik dla każdego nozdrza z osobna musi wynosić co najmniej 2 punkty)
    5. Utrzymujące się objawy występujące od co najmniej 12 tygodni przed włączeniem do badania
    6. Zgłaszany przez pacjenta wskaźnik niedrożności nosa o nasileniu umiarkowanym do ciężkiego (NBS) ≥2 podczas włączenia do badania
    7. Średnia punktacja NBS dla dwóch tygodni podczas randomizacji ≥1,5
    8. Łączny wynik testu SNOT-22 ≥20 podczas włączenia do badania i randomizacji
    9. Udokumentowana, rozpoznana przez lekarza astma
    10. Liczba eozynofilów we krwi >2% lub ≥150/μl w momencie włączenia do badania
    E.4Principal exclusion criteria
    1. Any nasal and/or sinus surgery within 3 months prior to enrolment
    2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:
    • Unilateral antrochoanal polyps
    • Nasal septal deviation that occludes at least one nostril
    • Current rhinitis medicamentosa
    • Allergic fungal rhinosinusitis or allergic fungal sinusitis;

    3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
    4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
    5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
    6. Currently pregnant or breastfeeding
    1. Pacjenci, którzy przeszli jakikolwiek zabieg chirurgiczny w obrębie nosa i (lub) zatok w ciągu 3 miesięcy poprzedzających włączenie do badania.
    2. Pacjenci, u których występują stany lub choroby współistniejące sprawiające, że osoby te nie kwalifikują się do oceny pod kątem równorzędnych głównych punktów końcowych dotyczących skuteczności uwzględniających, ale nie ograniczający się do:
    • jednostronne polipy choanalne;
    • skrzywienie przegrody nosa, które skutkuje niedrożnością przynajmniej jednego nozdrza
    • występujący aktualnie polekowy nieżyt nosa
    • alergiczny grzybicze zapalenie nosa i zatok lub alergiczne grzybicze zapalenie zatok;
    3. Klinicznie istotne choroby współistniejące, które mogłyby utrudnić interpretację wyników dotyczących skuteczności klinicznej i/lub bezpieczeństwa
    4. Otrzymywanie kortykosteroidów ogólnoustrojowych w ciągu 4 tygodni przed włączeniem do badania lub planowane podanie kortykosteroidów ogólnoustrojowych w trakcie badania.
    5. Przyjmowanie jakiegokolwiek zarejestrowanego lub eksperymentalnego preparatu biologicznego w okresie 6 miesięcy poprzedzających włączenie do badania
    6. Pacjentki będące obecnie w ciąży (lub planujące zajść w ciążę), karmiące piersią lub w okresie laktacji
    E.5 End points
    E.5.1Primary end point(s)
    Change form baseline in endoscopic total nasal polyp score (NPS)
    Change form baseline in mean nasal blockage score(NBS)
    Zmiana wyniku w skali endoskopowej łącznej oceny polipów nosa (NPS) względem oceny początkowej
    Zmiana średniego wyniku w skali oceny niedrożności nosa (NBS) względem oceny początkowej
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 56
    tydzień 56
    E.5.2Secondary end point(s)
    • Change from baseline in difficulty with sense of smell (DSS) score
    • Change from baseline in Lund Mackay score
    • Change from baseline in SinoNasal Outcome Test (SNOT-22) score.
    • Time to first nasal polyp surgery
    • Time to first SCS course for NP
    • Change from baseline in nasal symptom score(s)
    • Zmiana średniej oceny trudności związanych z węchem (ang. difficulty with sense of smell, DSS) względem oceny początkowej
    • Zmiana oceny w skali Lund i Mackay’a (ang. Lund Mackay Score, LMS) względem oceny początkowej
    • Zmiana wyniku testu parametrów dotyczących zatok i nosa (SNOT-22) względem oceny początkowej
    • Czas do pierwszej operacji w związku z CRSwNP
    • Czas do pierwszego kursu ogólnoustrojowych steroidów w związku z CRSwNP
    • Zmiana wyniku w skali objawów ze strony nosa względem oceny początkowej
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 56
    tydzień 56
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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
    Przedłużona faz otwartego leczenia po okresie podwójnie zaślepionym w grupach równoległych
    open label extension after double blind parallel group duration
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    United States
    Viet Nam
    Russian Federation
    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 study is planned to be when the last randomized patient completes one year in the open label extension.
    Zakończenie badania zaplanowano jako moment, w którym ostatni zrandomizowany pacjent zakończy roczny udział w przedłużonej otwartej fazie badania
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days7
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 275
    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)
    Upon completion of the initial 56-week treatment period, patients will be offered to participate in an Open Label Extension of benralizumab for at least one year. After completion of the study, patients
    will exit the trial and will return to care under their clinician’s direction.
    Po zakończeniu początkowego 56-tygodniowego okresu leczenia, pacjentom zostanie zaproponowane uczestnictwo w przedłużonej otwartej fazie badania benralizumabu przez co najmniej jeden rok. Po zakończeniu badania pacjenci opuszczą badanie i powrócą do opieki pod kierunkiem lekarza prowadzącego.
    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 Decision2022-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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