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    Summary
    EudraCT Number:2016-004677-40
    Sponsor's Protocol Code Number:M16-067
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-01-20
    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 number2016-004677-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
    Sperimentazione Multicentrica, Randomizzata, in Doppio Cieco, Controllata verso Placebo e di Induzione per Valutare l’Efficacia e la Sicurezza di Risankizumab in Soggetti con Colite Ulcerosa in Fase Attiva e di Grado da Moderato a Grave per cui è fallita una pregressa terapia con Biologici
    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 Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
    Sperimentazione per Valutare l’Efficacia e la Sicurezza di Risankizumab in Soggetti con Colite Ulcerosa in Fase Attiva e di Grado da Moderato a Grave per cui è fallita una pregressa terapia con Biologici
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM16-067
    A.5.4Other Identifiers
    Name:naNumber:M16-067
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    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 supportAbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbvie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0441628561090
    B.5.5Fax number0441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameRisankizumab
    D.3.2Product code [ABBV-066]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISANKIZUMAB
    D.3.9.2Current sponsor codeABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 typeHumanized IgG monoclonal antibody
    D.IMP: 2
    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 nameRisankizumab
    D.3.2Product code [ABBV-066]
    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 INNRISANKIZUMAB
    D.3.9.2Current sponsor codeABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 typeHumanized IgG monoclonal 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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study M16-067 comprises two sub-studies:
    The objective of Sub-Study 1 are to characterize the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC) and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.
    The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
    La Sperimentazione M16-067 si articola in due sottostudi:
    L’obiettivo del Sottostudio 1 è quello di caratterizzare l’efficacia, la sicurezza ed il profilo di farmacocinetica di risankizumab come trattamento di induzione in soggetti affetti da colite ulcerosa in fase attiva di grado da moderato a grave, e identificare l’appropriata dose di induzione di risankizumab da sottoporre a ulteriore valutazione nell’ambito del Sottostudio 2.
    L’obiettivo del Sottostudio 2 è quello di valutare l’efficacia e la sicurezza di risankizumab rispetto a placebo nell’indurre la remissione clinica in soggetti affetti da colite ulcerosa in fase attiva di grado da moderato a grave.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations at the Baseline Visit. In addition for sub-study 2 only: Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
    2.Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
    3. Active UC.
    4.Demonstrated intolerance or inadequate response to one or more biologic therapies.
    1.Soggetti di ambo i sessi di età compresa fra = 18 e = 80 anni, età minima per il rilascio personale del consenso previsto per soggetti adulti in accordo alla normativa locale, alla Visita di Baseline.In aggiunta, ed esclusivamente per il Sottostudio 2: ove permesso a livello locale, soggetti di età = 16 e < 18 anni il cui sviluppo è classificato come Stadio 5 secondo Tanner alla visita di Baseline.
    2.Diagnosi confermata di colite ulcerosa da almeno 3 mesi prima del Baseline.
    3.Colite ulcerosa in fase attiva
    4.Intolleranza o risposta inadeguata, confermate da evidenze, a una o più terapie biologiche.
    E.4Principal exclusion criteria
    1.Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation or ischemic colitis.
    2.Subject receiving prohibited medications and treatment.
    3.Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
    4.Subject with currently known complications of UC.
    1.Soggetto con diagnosi attuale di malattia di Crohn, malattia infiammatoria intestinale non classificata (IBD-U) oppure storia di colite da radioterapia oppure colite ischemica.
    2.Soggetto in trattamento con farmaci e trattamenti controindicati.
    3.Malattia infiammatoria che interessa esclusivamente il retto, secondo la valutazione
    endoscopica eseguita allo screening.
    4.Soggetto con presenza nota di complicanze associate alla colite ulcerosa
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with clinical remission per Adapted Mayo score at Week 12
    Percentuale di soggetti con remissione clinica in base al punteggio Adapted Mayo score alla Settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    1. Proportion of subjects with endoscopic improvement at Week 12.
    2. Proportion of subjects achieving clinical remission at Week 12 in subjects with a Full Mayo score of 6 to 12 at Baseline.
    3. Proportion of subjects achieving clinical response at Week 12.
    4. Proportion of subjects achieving clinical response at Week 4.
    5. Proportion of subjects with endoscopic remission at Week 12.
    6. Proportion of subjects with hospitalizations through Week 12.
    7. Proportion of subjects with mucosal healing at Week 12.
    8. Change from Baseline in UC-Symptom Questionnaire (UC-SQ) at Week 12.
    9. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12.
    10. Change from Baseline in Short Form-36 at Week 12.
    11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) at Week 12.
    12. Proportion of subjects with UC-related surgeries through Week 12.
    1. Percentuale di soggetti con miglioramento endoscopico alla Settimana 12.
    2. Percentuale di soggetti che ottengono la remissione clinica in base al punteggio completo Full Mayo score compreso fra 6 e 12 al Baseline.
    3. Percentuale di soggetti che ottengono la risposta clinica alla Settimana 12.
    4. Percentuale di soggetti che ottengono la risposta clinica alla Settimana 4.
    5. Percentuale di soggetti con remissione endoscopica alla Settimana 12.
    6. Percentuale di soggetti con ospedalizzazioni fino alla Settimana 12 compresa.
    7. Percentuale di soggetti con guarigione della mucosa alla Settimana 12.
    8. Variazione rispetto al Baseline del punteggio UC-SQ (UC-Symptom Questionnaire) alla Settimana 12.
    9. Variazione rispetto al Baseline del punteggio IBDQ (Inflammatory Bowel Disease Questionnaire) alla Settimana 12.
    10. Variazione rispetto al Baseline del punteggio Short Form-36 alla Settimana 12.
    11. Variazione rispetto al Baseline del punteggio FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) alla Settimana 12.
    12. Percentuale di soggetti sottoposti a interventi chirurgici associati alla colite ulcerosa fino alla
    Settimana 12 compresa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 12
    2. Baseline, Week 12
    3. Week 12
    4. Week 4
    5. Week 12
    6. Week 12
    7. Week 12
    8. Baseline, Week 12
    9. Baseline, Week 12
    10. Baseline, Week 12
    11. Baseline, Week 12
    12. 12 weeks
    1. Settimana 12
    2. Baseline, Settimana 12
    3. Settimana 12
    4. Settimana 4
    5. Settimana 12
    6. Settimana 12
    7. Settimana 12
    8. Baseline, Settimana 12
    9. Baseline, Settimana 12
    10. Baseline, Settimana 12
    11. Baseline, Settimana 12
    12. 12 Settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial15
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA265
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Croatia
    Czechia
    Denmark
    Egypt
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 660
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 720
    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)
    na
    na
    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 Decision2018-08-22
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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