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    Summary
    EudraCT Number:2014-000720-18
    Sponsor's Protocol Code Number:CNTO1959PSO3002
    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:2014-09-10
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2014-000720-18
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis with Randomized Withdrawal and Retreatment
    Wieloośrodkowe, randomizowane, podwójnie zaślepione badanie kliniczne fazy 3 z porównaniem względem placebo oraz komparatora aktywnego, służące ocenie skuteczności i bezpieczeństwa guselkumabu w leczeniu pacjentów z umiarkowaną do ciężkiej łuszczycą plackowatą z randomizowanym przerwaniem leczenia i leczeniem ponownym.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Guselkumab in the Treatment of Participants with Moderate to Severe Plaque-Type Psoriasis with Randomized Withdrawal and Retreatment
    badanie kliniczne dla pacjentów z umiarkowaną do ciężkiej łuszczycą plackowatą z randomizowanym przerwaniem leczenia i leczeniem ponownym.
    A.3.2Name or abbreviated title of the trial where available
    VOYAGE 2
    VOYAGE 2
    A.4.1Sponsor's protocol code numberCNTO1959PSO3002
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 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 nameGuselkumab
    D.3.2Product code CNTO1959
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB130392
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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 nameHumira
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    D.8 Placebo: 2
    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
    Moderate to Severe Plaque Type Psoriasis
    Umiarkowana i ciężka postać łuszczycy plackowatej.
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Łuszczyca
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue 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 efficacy of guselkumab in the treatment of subjects with moderate to severe plaque-type psoriasis.
    • To assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis.
    • Ocena skuteczności guselkumabu w leczeniu pacjentów z umiarkowaną do ciężkiej łuszczycą plackowatą.
    • Ocena bezpieczeństwa i tolerancji leczenia guselkumabem u pacjentów z umiarkowaną do ciężkiej łuszczycą plackowatą.
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of guselkumab to adalimumab in subjects with moderate to severe plaque-type psoriasis.
    • To evaluate the maintenance of response to guselkumab in subjects continuing on a 100 mg q8w regimen compared with the maintenance of response in subjects who have active treatment withdrawn.
    • To evaluate the effect of treatment with guselkumab on other measures of signs and symptoms of psoriasis.
    • To evaluate the effect of treatment with guselkumab on health-related quality of life and health economic outcomes.
    Porównanie skuteczności guselkumabu ze skutecznością adalimumabu u pacjentów z umiarkowaną do ciężkiej łuszczycą plackowatą.
    • Ocena podtrzymania odpowiedzi na guselkumab u pacjentów kontynuujących przyjmowanie leku w dawce 100 mg według schematu co 8 tygodni, w porównaniu z podtrzymaniem odpowiedzi u pacjentów, u których zaprzestano stosowania leku czynnego.
    • Ocena wpływu leczenia guselkumabem na inne miary oznak i objawów łuszczycy.
    • Ocena wpływu leczenia guselkumabem na zależną od stanu zdrowia jakość życia oraz na wyniki w zakresie ekonomiki zdrowia.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Skin biopsy samples will be collected from a subset of subjects who consent to participate in the optional biopsy substudy. Enrollment in the biopsy study will be optional and will include approximately 120 to 150 subjects at selected study sites. Only subjects who consent to participate in the optional biopsy substudy will undergo collection of these samples. Biopsies will be used for assessment of gene expression and T cell repertoire. Whole blood samples will be collected from the subset of subjects who consent to participate in the optional biopsy substudy. Peripheral blood mononuclear cells (PBMCs) will be isolated from these samples and processed for immune repertoire analysis with assessment of T-cell receptor clonality.
    Overview photographs of the whole body as well as photographs of selected psoriatic skin lesions will be taken at a subset of study sites in patients who provide an additional consent.
    Protocol A0, dated 10 July 2014
    Próbki biopsji skóry pobrane zostaną od Pacjentów, którzy wyrażą zgodę na udział w podbadaniu. Właczenie do podbadania będzie opcjonalne i będzie zawierało ok. 120-150 pacjentów w wybranych ośrodkach badawczych. Próbki będą użyte do oceny ekspresji genów oraz zebranie informacji o komórkach T.
    Próbka krwi zostanie pobrana od pacjentów, którzy udzialą dodatkowej zgody na udział w podbadaniu. Mononuklearne komórki (PBMCs) będą wyizolowane z krwi obwodowej i poddane ocenie pod kątem immunologicznym oraz klonalności receptorów komórek T.
    Zdjęcia fotograficznr całego ciała oraz powierzchni skóry z wybranymi zmianami będą wykonane pacjentom, którzy podpisali osobne formularze zgody.
    Wersja podbadań: Protokół A1; wersja finalna z dnia 12 luty 2015
    E.3Principal inclusion criteria
    -Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
    - Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline - Have an Investigator’s Global Assessment (IGA) score >=3 at Screening and at Baseline
    - Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
    - Must be a candidate for either systemic therapy or phototherapy for psoriasis
    1. Diagnoza łuszczycy plackowatej (wraz lub bez łuszczycowego zapalenia stawów) w ciągu 6 miesięcy od pierwszego podania leku badanego.
    2. Wartości wskaźnika rozległości i ciężkości łuszczycy (ang. Psoriasis Area and Severity Index, PASI) większy lub równy 12 w okresie przesiewowym oraz w dniu randomizacji.
    3. Wartość skali „Globalne Ocena Badacza” (IGA) większa lub równa 3 12 w okresie przesiewowym oraz w dniu randomizacji.
    4. Zajęcie procesem chorobowym ≥10% całkowitej powierzchni ciała.
    5. Pacjenci muszą być kandydatami do leczenia ogólnoustrojowego lub fototerapii łuszczycy i dozwolone jest przyjmowanie przez nich uprzednio różnych terapii ogólnoustrojowych lub fototerapii z powodu łuszczycy
    E.4Principal exclusion criteria
    - Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
    - Participants who have ever received guselkumab or adalimumab
    - History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
    - Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
    1. Wcześniejsza historia lub aktualne objawy ciężkiej, postępującej, niekontrolowanej choroby układu moczowego, wątroby, sercowo-naczyniowego, oddechowego, pokarmowego, endokrynologicznego, nerwowego, reumatologicznych, psychiatrycznych oraz metabolicznych oraz inne schorzenie, które w opinii lekarza powoduje, że uczestnictwo w badaniu nie jest w najlepszym interesie pacjenta lub limituje, przeszkadza wykonanie procedur wymaganych przez protokół.
    2. Nieplackowata postać łuszczycy (np. kroplista, erytrodermalna, krostkowa) oraz obecna łuszczyca indukowana lekami (np. nowa łuszczyca lub nasilenie objawów od beta-blokerów, litu oraz blokerów kanału wapniowego)
    3. Wcześniejsze przyjmowanie guselkumabu lub adalimumabu
    4. Ciąża, karmienie piersią lub planowanie ciąży (zarówno kobiety jak mężczyźni) w ciągu 5 miesięcy od ostatniej dawki leku badanego.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are the proportions of subjects who achieve an IGA score of cleared (0) or minimal (1) and the proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the placebo group.
    Określenie proporcji pacjentów, którzy osiągnęli ocenę skali IGA 0 lub 1 oraz określenie proporcji pacjentów, którzy osiągnęli wynik skali PASI 90 w tygodniu 16 w porównaniu do grupy placebo i guselkumabu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Wizyta w tygodniu 16
    E.5.2Secondary end point(s)
    • The proportion of subjects who achieve an IGA score of cleared at Week 24, comparing the guselkumab group and the adalimumab group.
    • The proportion of subjects who achieve an IGA score of cleared or minimal at Week 24, comparing the guselkumab group and the adalimumab group.
    • The proportion of subjects who achieve a PASI 90 response at Week 24, comparing the guselkumab group and the adalimumab group.
    • The time to loss of PASI 90 response through Week 48, comparing subjects randomized to placebo and subjects randomized to continue guselkumab 100 mg q8w at Week 28.
    • The change from baseline in DLQI score at Week 16, comparing the guselkumab group and the placebo group.
    • The proportion of subjects who achieve an IGA score of cleared or minimal at Week 16, comparing the guselkumab group and the adalimumab group.
    • The proportion of subjects who achieve a PASI 90 response at Week 16, comparing the guselkumab group and the adalimumab group.
    • The proportion of subjects who achieve a PASI 75 response at Week 16, comparing the guselkumab group and the adalimumab group.
    • The proportion of subjects who achieve an ss-IGA score of absence of disease or very mild disease and have at least a 2-grade improvement from baseline at Week 16, comparing the guselkumab group and the placebo group among randomized subjects with scalp psoriasis and an ss-IGA score ≥2 at baseline.
    • The change from baseline in PSSD symptom score at Week 16, comparing the guselkumab group and the placebo group.
    • The proportion of subjects who achieve a PSSD symptom score=0 at Week 24, comparing the guselkumab group and adalimumab group among randomized subjects with a baseline PSSD symptom score ≥1.


    Other Secondary Endpoints

    Placebo Comparisons

    • The proportion of subjects who achieve an IGA score of cleared and the proportion of subjects achieving an IGA score of mild or better (≤2) at Week 16.
    • The proportion of subjects who achieve a PASI 100 response, PASI 75 response, and a PASI 50 response at Week 16.
    • The percent improvement from baseline in PASI response through Week 16.
    • The proportion of subjects who achieve a DLQI score=0 or 1 at Week 16 among randomized subjects with baseline DLQI>1.
    • The proportion of subjects with a reduction of 5 or more points in DLQI score at Week 16.
    • The percent improvement from baseline in NAPSI at Week 16 among randomized subjects with nail psoriasis at baseline.
    • The proportion of subjects who achieve an f-PGA score of clear or minimal and have at last 1 grade improvement from baseline at Week 16 among randomized subjects with f PGA ≥2 at baseline.
    • The proportion of subjects who achieve a PSSD symptom score=0 at Week 16 among randomized subjects with a baseline PSSD symptom score ≥1.
    • The proportion of subjects who achieve a PSSD sign score=0 at Week 16 among randomized subjects with a baseline PSSD sign score ≥1.
    • The change from baseline in individual scale score of PSSD components at Week 16 among randomized subjects.
    • The proportion of subjects who achieve PSSD individual scale score of 0 at Week 16 among randomized subjects with scale score ≥1 at baseline.
    • The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and a reduction of at least 2 grades on the hf-PGA scale from baseline at Week 16 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score ≥2 at baseline.
    • Change from baseline in the physical and mental component summary scores of SF-36 at Week 16.
    • The change from baseline in HADS at Week 16.
    • The change from baseline in WLQ at Week 16.

    Guselkumab versus Adalimumab

    • The proportion of subjects who achieve a PASI 75 response and a PASI 100 response at Week 24.
    •The proportion of subjects who achieve an ss-IGA score of absence of disease or very mild disease and at least a 2-grade improvement from baseline at Week 24 among randomized subjects with scalp psoriasis and an ss-IGA score ≥2 at baseline.
    • The percent improvement from baseline in NAPSI at Week 24 among randomized subjects with nail psoriasis at baseline.
    • The proportion of subjects who achieve an f-PGA score of clear or minimal and have at least a 1-grade improvement from baseline at Week 24 among subjects with f-PGA ≥2 at baseline.
    • The proportion of subjects who achieve an hf-PGA score of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline at Week 24 among randomized subjects with hand and/or foot psoriasis and an hf-PGA score ≥2 at baseline.
    • The proportion of subjects who achieve a DLQI score=0 or 1 at Week 24 among randomized subjects with baseline DLQI>1.
    • The change from baseline in the PSSD symptom score at Week 24.

    Please see protocol for other secondary endpoints
    • odsetek pacjentów, którzy osiągnęli wynik w skali IGA0 w
    Tygodniu 24, porównując do grupy przyjmującej guselkumab i adalimumab.
    • odsetek osób osiągających wynik w skali IGA wyczyszczone lub minimalna zmiana w 24 tygodniu, w porównaniu do grupy przyjmującej guselkumab i adalimumab.
    • odsetek pacjentów, którzy uzyskali odpowiedzi na poziomie 90 w skali PASI w tygodniu
    24, w porównaniu do grupy przyjmującej guselkumab i adalimumab.
    • czas do utraty odpowiedzi na poziomie 90 w skali PASI w 48 tygodniu, porównując pacjentów zrandomizowanych do grupy przyjmującej placebo i pacjentów zrandomizowanej do kontynuacji przyjmowania 100 mg q8w guselkumabu w tygodniu 28smym.
    •zmiana od wartości początkowej DLQI w tygodniu 16tym w porównaniu grup przyjmujących guselkumab i adalimumab.
    • odsetek osób osiągających w skali IGA wyczyszczone lub minimalna zmiana w 16tym tygodniu, w porównaniu grup przyjmujących guselkumab i adalimumab.
    • odsetek pacjentów, którzy osiągnęli odpowiedź w skali PASI na poziomie 90 w tygodniu 16tym w porównaniu grup przyjmujących guselkumab i adalimumab.
    • odsetek pacjentów, którzy osiągnęli odpowiedź w skali PASI na poziomie 75 w tygodniu 16tym w porównaniu grup przyjmujących guselkumab i adalimumab.
    • odsetek pacjentów którzy osiągają wynik w skali SS-IGA wskazujący na brak lub bardzo łagodną postać choroby przy co najmniej 2 stopniowej poprawie choroby od wartości wyjściowej w tygodniu 16tym w porównaniu grup przyjmujących guselkumab i placebo spośród pacjentów zrandomizowanych z grupy łuszczycy skóry głowy i wyniku SS-IGA ≥2 na początku badania.
    • Zmiana od wartości początkowej w skali PSSD nasilenia objawów w 16 tygodniu, porównując grupę przyjmującą guselkumab i grupę placebo.
    • Odsetek pacjentów, którzy osiągają wynik objawów w skali PSSD = 0 w tygodniu 24, porównując grupę grupe przyjmującą guselkumab i adalimumab spośród pacjentów zrandomizowanych z wartością początkową PSSD ≥1




    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16/ Week 24/ Week 48
    Wizyty w tygodniach 16/24/48
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Australia
    Canada
    Czech Republic
    Germany
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    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: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state265
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 1000
    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)
    There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.
    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 Decision2014-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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