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    Summary
    EudraCT Number:2017-002465-22
    Sponsor's Protocol Code Number:M16-011
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-06
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2017-002465-22
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
    Randomizirana, dvojno slepa raziskava 3. faze za primerjavo risankizumaba in placeba pri bolnikih z aktivnim psoriatičnim artritisom (PsA), ki imajo v anamnezi nezadosten odziv ali neprenašanje zdravljenja z vsaj enim imunomodulirajočim antirevmatičnim zdravilom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD)Therapy
    Raziskava, ki primerja Risankizumab s placebom pri bolnikih z aktivnim psoriatičnim artritisom (PsA), ki imajo v anamnezi nezadosten odziv ali neprenašanje zdravljenja z vsaj enim imunomodulirajočim antirevmatičnim zdravilom (DMARD)
    A.4.1Sponsor's protocol code numberM16-011
    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, Vanwell Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    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 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 INNRISANKIZUMAB
    D.3.9.1CAS number 1612838-76-2
    D.3.9.2Current sponsor codeABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Psoriatic Arthritis.
    Psoriatični artritis
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis is an inflammatory disease where the immune system attacks healthy joints and skin causing pain, swelling, and stiffness in the joints, and red scaly patches on the skin.
    Psoriatični artritis je vnetna bolezen, pri kateri imunski sistem napade zdrave sklepe in kožo, ki povzroča bolečino, oteklino in togost v sklepih in rdeče luskaste lise na koži.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    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 efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis.

    Primerjava učinkovitosti 150 mg risankizumaba in placeba za zdravljenje znakov in simptomov PsA v študijski populaciji
    E.2.2Secondary objectives of the trial
    Period 1 (Double Blind): 1.To compare the efficacy of Risankizumab 150 mg versus placebo for the inhibition of progression of structural damage as assessed by radiographs in the study population. 2.To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis.

    Period 2: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1.
    1. obdobje (dvojno slepo): 1. Primerjava učinkovitosti 150 mg risankizumaba in placeba za zavrtje napredovanja radiografsko ocenjene strukturne okvare v študijski populaciji.
    2. Primerjava varnosti in prenašanja 150 mg risankizumaba in placeba pri bolnikih s psoriatičnim artritisom.

    2. obdobje: Ocena dolgoročne varnosti, prenašanja in učinkovitosti 150 mg risankizumaba pri preiskovancih, ki so dokončali 1. obdobje.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
    • Subject has active disease at Baseline
    • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.
    • Presence of either at Screening:
    1. ≥ 1 erosion on radiograph as determined by central imaging review or;
    2. hs-CRP ≥ 3.0 mg/L.
    • Subject has demonstrated an inadequate response to previous or current treatment with at least 1 csDMARD OR subject must have an intolerance to or contraindication for csDMARDs as determined by the investigator.
    • Klinična diagnoza PsA s pojavom simptomov vsaj 6 mesecev pred presejalnim obiskom in izpolnjevanje razvrstitvenih meril za PsA (CASPAR) na presejalnem obisku.
    • Preiskovanec ima na izhodiščnem obisku aktivno bolezen
    • Diagnoza aktivne psoriaze v plakih z vsaj enim psoriatičnim plakom s premerom ≥ 2 cm ali spremembe nohtov, ki se skladajo s psoriazo, na presejalnem obisku.
    • Ob presejanju prisotnost enega od naslednjega dvojega:
    1. ≥ 1 erozije na radiografskem posnetku, ugotovljeno s centralnim pregledom posnetka, ali
    2. hsCRP ≥ 3,0 mg/l.
    • Preiskovanec mora imeti dokazan nezadosten odziv na predhodno ali trenutno zdravljenje z vsaj 1 ksIA ali mora imeti preiskovanec intoleranco ali kontraindikacijo za ksIA, kot to presodi raziskovalec
    E.4Principal exclusion criteria
    • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
    • Subject has a known hypersensitivity to Risankizumab.
    • Subject has previous treatment with biologic agent.
    • Preiskovanec je, po mnenju raziskovalca, iz kakršnega koli razloga, neprimeren kandidat za študijo.
    • Preiskovanec ima znano preobčutljivost na Risankizumab.
    • Preiskovanec je predhodno zdravljen z biološkimi zdravili
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 Response (ACR20) at Week 24.
    Primarni opazovani dogodek je delež preiskovancev, ki po 24 tednih dosežejo odziv ACR (American College of Rheumatology) 20.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24.
    Teden 24
    E.5.2Secondary end point(s)
    1.   Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at Week 24;
    2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a BSA ≥ 3% at Baseline);
    3. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at Week 24;
    4. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24;
    5. Change from Baseline in Fingernail-Physician Global Assessment (PGA-F, US)/ modified Nail Psoriasis Severity Index (mNAPSI, ex-US) at Week 24 (in the subset of subjects with nail psoriasis at Baseline); Note: PGA-F and mNAPSI assessments will be obtained in all patients, whether US or ex-US.
    6. Change from Baseline in Leeds Enthesitis Index (LEI) at Week 24 (in the subset of subjects with enthesitis at the LEI sites at Baseline);
    7. Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24 (in the subset of subjects with dactylitis at Baseline);
    8. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24;
    9. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.
    1. Sprememba indeksa HAQ-DI (Health Assessment Questionnaire – Disability Index) od izhodišča do 24. tedna
    2. Delež preiskovancev, ki po 24 tednih dosežejo odziv PASI (Psoriasis Area Severity Index) 90 (v podskupini preiskovancev z izhodiščno prizadetostjo ≥ 3 % TP)
    3. Sprememba prilagojene celotne Sharpove ocene (PsA-mTSS) od izhodišča do 24. tedna
    4. Delež bolnikov, ki po 24 tednih dosežejo minimalno aktivnost bolezni (MDA – Minimal Disease Activity)
    5. Sprememba zdravnikove globalne ocene nohtov na rokah (PGA-F, v ZDA)/prilagojenega indeksa izrazitosti psoriaze nohtov (mNAPSI, zunaj ZDA) po 24 tednih v primerjavi z izhodiščem (v podskupini preiskovancev, ki so izhodiščno imeli psoriazo nohtov). Opomba: Oceni PGA-F in mNAPSI bosta narejeni za vse bolnike, najsi bo v ZDA ali zunaj ZDA.
    6. Sprememba indeksa LEI (Leeds Enthesitis Index) po 24 tednih v primerjavi z izhodiščem (v podskupini preiskovancev z izhodiščno prisotnim entezitisom na mestih LEI)
    7. Sprememba indeksa LDI (Leeds Dactylitis Index) po 24 tednih v primerjavi z izhodiščem (v podskupini preiskovancev z izhodiščno prisotnim daktilitisom)
    8. Sprememba povzetka telesne komponente (PCS – Physical Component Summary) vprašalnika SF 36 (Short Form Health Survey s 36 postavkami) po 24 tednih v primerjavi z izhodiščem
    9. Sprememba ocene FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) po 24 tednih v primerjavi z izhodiščem.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24.
    Teden 24
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA144
    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
    Argentina
    Australia
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    Last protocol contact or last protocol follow-up of the last subject, whichever is longer.
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months72
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months72
    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: 712
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 490
    F.4.2.2In the whole clinical trial 880
    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)
    Active subjects randomized to Risankizumab: subjects will continue on study treatment throughout the study for a period of up to 1456 days/208 weeks/4 years or until premature discontinuation of study drug. At the subject's last study visit, the investigator will discuss the appropriate subsequent treatment with the subject. Risankizumab may not be commercially available. AbbVie will not provide Risankizumab or any other therapy once the subject's participation is concluded.
    Na zadnjem študijskem obisku, zdravnik raziskovalec se bo pogovoril o ustreznem naknadnem zdravljenju s preiskovancem. Risankizumab morda ne bo na voljo na tržišču. AbbVie ne bo zagotovil zdravljenja z Risankizumab ali katerokoli drugo terapijo, ko bo sodelovanje končano.
    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 Decision2019-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
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