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    Summary
    EudraCT Number:2007-004687-47
    Sponsor's Protocol Code Number:M10-255
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-09
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004687-47
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind Study Comparing the Safety and Efficacy of ABT-874 to Methotrexate in Subjects with Moderate to Severe Chronic Plaque Psoriasis, Incorporating Amendment 1, 2 and 3.
    Studio multicentrico, randomizzato, in doppio cieco, di Fase 3, per confrontare la sicurezza e l efficacia di ABT-874 rispetto al metotrexato (MTX), in soggetti con psoriasi a placche cronica da moderata a severa (comprensivo di Emendamenti 1, 2 & 3).
    A.4.1Sponsor's protocol code numberM10-255
    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 SponsorAbbott GmbH & Co. K.G.
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameABT-874
    D.3.2Product code NA
    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 INNSelective immunosuppressive agents
    D.3.9.2Current sponsor codeABT-874
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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 No
    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 MTX HEXAL 2.5 MG tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 typeNon Applicabile
    D.IMP: 3
    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 MTX HEXAL 2.5 mg tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 typeNon Applicabile
    D.IMP: 4
    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 MTX HEXAL 2.5 mg tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 typeNon Applicabile
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    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
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral 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 chronic plaque psoriasis
    psoriasi a placche cronica da moderata a grave
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 compare the short-term and long-term clinical efficacy, safety and tolerability of ABT-874 compared to MTX in the treatment of moderate to severe chronic plaque psoriasis over a 24 and 52-week period.
    Confrontare l`efficacia clinica, la sicurezza e la tollerabilita` a breve e a lungo termine di ABT-874 rispetto a MTX, nel trattamento di soggetti con psoriasi a placche cronica da moderata a severa nell`arco di un periodo di 24 e 52 settimane.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females 18 years of age and over. 2. Clinical diagnosis of psoriasis for at least 6 months as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the Principal Investigator. 3. Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week 0) visits as determined by subject interview of his/her medical history. 4. Moderate to severe plaque psoriasis defined by &#61619; 10% Body Surface Area (BSA) involvement at the Baseline (Week 0) visit. 5. PGA of at least moderate disease (defined as PGA &#61619; 3) at the Baseline (Week 0) visit. 6. PASI score of &#61619; 12 at the Baseline (Week 0) visit. 7. Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents. 8. Women are eligible to participate in the study if they meet one of the following criteria: Women of childbearing potential must undergo monthly pregnancy testing during the study and agree to use two of the following methods of contraception throughout the study and for 6 months after the last dose of study drug: &#9675; Oral contraceptives; &#9675; Transdermal contraceptives; &#9675; Injectable or implantable methods; &#9675; Intrauterine devices; and &#9675; Barrier methods (diaphragm with spermicide, condom with spermicide). Subjects using oral or parenteral forms of contraceptives must have been practicing birth control for at least three months prior to study drug administration. Women who are postmenopausal (for at least one year), sterile, or hysterectomized; Women who have undergone tubal ligation will be required to undergo monthly pregnancy testing during the duration of the study and agree to use a second form of contraception which includes: &#9675; Oral contraceptives; &#9675; Transdermal contraceptives; &#9675; Injectable or implantable methods; &#9675; Intrauterine devices; and &#9675; Barrier methods (diaphragm with spermicide, or condom with spermicide). 9. Sexually active male subjects (including males who have had a vasectomy) are able to participate in the study if they use effective contraception (i.e. condoms with spermicide) during the study and 6 months after study completion. 10. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening. 11. Able and willing to give written informed consent and to comply with the requirements of this study protocol.
    1. Maschi e femmine di almeno 18 anni di eta`. 2. Diagnosi clinica di psoriasi da almeno 6 mesi come accertato da colloquio col soggetto relativo alla sua anamnesi medica e conferma della diagnosi mediante esame obiettivo da parte del Medico sperimentatore. 3. Psoriasi a placche stabile da almeno 2 mesi prima delle visite di screening e al basale (Settimana 0) come accertato da colloquio col soggetto relativo alla sua anamnesi medica. 4. Psoriasi a placche da moderata a severa definita da interessamento di una superficie corporea (BSA) &#61619; 10% alla visita al basale (Settimana 0). 5. Punteggio PGA indicante malattia almeno moderata (definita da punteggio PGA &#61619; 3) alla visita al basale (Settimana 0). 6. Punteggio PASI &#61619; 12 alla visita al basale (Settimana 0). 7. Soggetto candidato a terapia sistemica o fototerapia e sofferente di psoriasi attiva nonostante il trattamento con agenti topici. 8. Le donne sono idonee a partecipare allo studio se soddisfano uno dei seguenti criteri. Le donne in eta` fertile dovranno sottoporsi a test mensili di gravidanza nel corso dello studio e acconsentire a utilizzare due dei seguenti metodi contraccettivi per tutta la durata dello studio e per 6 mesi dopo l'assunzione dell'ultima dose del farmaco in studio: &#9675; contraccettivi orali &#9675; contraccettivi transdermici &#9675; metodi iniettabili o impiantabili &#9675; spirali anticoncezionali e &#9675; metodi barriera (diaframma con spermicida, profilattico con spermicida) I soggetti che utilizzeranno forme di contraccezione orali o parenterali dovranno avere praticato questo tipo di contraccezione per almeno tre mesi prima della somministrazione del farmaco in studio. Donne in fase di post menopausa (da almeno un anno), sterili o isterectomizzate. Le donne che hanno subito la legatura tubarica dovranno sottoporsi a test di gravidanza mensili per tutta la durata dello studio e acconsentire ad utilizzare una seconda forma di contraccezione come: &#9675; contraccettivi orali &#9675; contraccettivi transdermici &#9675; metodi iniettabili o impiantabili &#9675; spirali anticoncezionali e &#9675; metodi barriera (diaframma con spermicida o profilattico con spermicida) 9. I soggetti maschi sessualmente attivi (compresi i maschi sottoposti a vasectomia) potranno partecipare allo studio se utilizzeranno un efficace mezzo di contraccezione (p. es., profilattici con spermicida) durante tutto lo svolgimento dello studio e per 6 mesi dopo il completamento dello studio. 10. Soggetti giudicati in stato di buona salute generale come accertato dal Medico sperimentatore in base ai risultati della anamnesi medica, del profilo di laboratorio, dell'esame obiettivo, della radiografia toracica (CXR) e dell'elettrocardiogramma a 12 derivazioni (ECG) eseguiti allo screening. 11. Soggetti in grado di, e disposti a, fornire il consenso informato scritto e a rispettare i requisiti di questo protocollo di studio.
    E.4Principal exclusion criteria
    1. Previous exposure to systemic anti-IL-12 therapy, including ABT-874. 2. Subject has previous exposure to MTX. 3. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. 4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis. 5. History of an allergic reaction or significant sensitivity to constituents of study drug. 6. Cannot discontinue topical therapies for the treatment of psoriasis. 7. Cannot avoid UVB phototherapy for at least 2 weeks prior to the Baseline (Week 0) visit and during the study. 8. Cannot avoid PUVA phototherapy for at least 4 weeks prior to the Baseline (Week 0) visit and during the study. 9. Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis, during the study: 10. Subject is taking or requires oral or injectable corticosteroids during the study. 11. Poorly controlled medical conditions. 12. Subject has a history of clinically significant hematologic. 13. Subject has infection or risk factors for severe infections. 14. History of malignancies other than successfully treated basal cell carcinoma, non metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ. 15. History of major immunologic reaction. 16. Exacerbation of asthma requiring hospitalization in the ten years prior to Screening. 17. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or for six months after study completion. 18. Screening clinical laboratory analyses show any of abnormal results detailed in protocol 19. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol. 20. Subject has a known allergic hypersensitivity to MTX. 21. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 22. For any reason, subject is considered by the Principal Investigator to be an unsuitable candidate to receive ABT-874.
    1. Precedente esposizione alla terapia sistemica anti-IL-12, comprendente ABT-874. 2. Soggetti che abbiano in precedenza assunto MTX. 3. Diagnosi di psoriasi eritrodermica, psoriasi pustolosa generalizzata o localizzata, psoriasi indotta da farmaci o aggravata da farmaci, o nuova comparsa di psoriasi guttata. 4. Diagnosi di altre malattie attive della pelle o infezioni cutanee (batteriche, fungine o virali) che potrebbero interferire con la valutazione della psoriasi. 5. Anamnesi di reazione allergica o significativa sensibilita` ai costituenti del farmaco in studio. 6. Impossibilita` di interrompere le terapie topiche per il trattamento della psoriasi 7. Impossibilita` di evitare la fototerapia con raggi UVB per almeno 2 settimane prima della visita al basale (Settimana 0) e durante lo studio. 8. Impossibilita` di evitare la fototerapia con raggi PUVA per almeno 4 settimane prima della visita al basale (Settimana 0) e durante lo studio. 9. Impossibilita` di interrompere le terapie sistemiche per il trattamento della psoriasi, o le terapie sistemiche riconosciute atte a migliorare la psoriasi, durante lo studio 10. Soggetti che assumono o richiedono corticosteroidi orali o iniettabili durante lo studio. 11. Condizioni mediche insufficientemente controllate 12. Soggetti con anamnesi di malattia ematologica clinicamente significativa. 13. Soggetti con infezioni o con fattori di rischio per gravi infezioni 14. Anamnesi di tumori maligni diversi dal carcinoma a cellule basali, dal carcinoma cutaneo a cellule squamose non metastatico o del carcinoma cervicale in situ trattati con successo. 15. Anamnesi di rilevante reazione immunologica 16. Esacerbazione dell'asma che abbia richiesto il ricovero ospedaliero nei dieci anni precedenti lo screening . 17. Soggetto femminile in gravidanza o che allatta al seno o che intende rimanere incinta nel corso dello studio o nei 6 mesi seguenti al completamento dello studio. 18. Se le analisi cliniche di laboratorio allo screening evidenziano uno o piu` valori anomali come descritto in protocollo 19. Recente anamnesi di abuso di sostanze o di malattia psichiatrica che potrebbe precludere la 'compliance' al protocollo. 20. Soggetto con ipersensibilita` nota all'MTX. 21. Soggetti con rari problemi ereditari di intolleranza al galattosio, deficienza di Lapp lattasi o malassorbimento di glucosio-galattosio. 22. Soggetti che, per qualsiasi motivo, siano considerati dal Medico sperimentatore come non idonei a ricevere l'ABT-874.
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of subjects who achieve a PASI 75 response defined as a at least 75% reduction in PASI score relative to Baseline, at Week 24. 2. The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24. 3. The proportion of subjects who achieve a PASI 75 response defined as a at least 75% reduction in PASI score relative to Baseline at Week 52. 4. The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52.
    1. La percentuale di soggetti che alla Settimana 24 conseguono una risposta PASI 75, definita come una riduzione di almeno il 75% dell'indice PASI rispetto al Basale. 2. La percentuale di soggetti che conseguono un punteggio PGA di 0 o 1 alla Settimana 24. 3. La percentuale di soggetti che conseguono alla Settimana 52 una risposta di PASI 75, definita come una riduzione di almeno il 75 % dell`indice PASI rispetto al Basale. 4. La percentuale di soggetti che conseguono un indice PGA di 0 o 1 alla Settimana 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 No
    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) 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The date of last subject's scheduled visit or the actual date of the follow up contact, whichever is longer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 2008-04-09. Yes
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 281
    F.4.2.2In the whole clinical trial 317
    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)
    All subjects who have enrolled in the M10-255 study will be eligible to enroll in the M10-016 Open-Label study if they meet the following criteria: subjects who complete through Week-24 and have not achieved an adequate response as defined in the protocol, or after Week¿24 have lost their response as defined in the protocol, or have successfully completed the 52-week study. Subjects who choose not to enroll in the Open Label Study will be advised of other treatment options by their investigator
    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 Decision2008-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
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