Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-003189-15
    Sponsor's Protocol Code Number:S61472
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-003189-15
    A.3Full title of the trial
    STRAUSS: responSe To ustekinumab foR Anti-tnf IndUced pSoriasiform Skin lesions
    STRAUSS: antwoord van anti-TNF geïnduceerde psoriasiforme huidletsels aan ustekinumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Using gen and protein expression to gain insights in the development of psoriasiform skin lesions under anti-TNF therapy, and predicting response to ustekinumab.
    Gen-en eiwitexpressie gebruiken om meer inzicht te verkrijgen in de ontwikkeling van psoriasiforme huidletsels onder anti-TNF behandeling, alsook respons te voorspellen van dergelijke huidletsels op ustekinumab
    A.3.2Name or abbreviated title of the trial where available
    STRAUSS
    STRAUSS
    A.4.1Sponsor's protocol code numberS61472
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03629379
    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 SponsorUniversity Hospitals Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Hospitals Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospitals Leuven
    B.5.2Functional name of contact pointClinical Trial Center UZ Leuven
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+321634 19 98
    B.5.6E-mailctc@uzleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Solution for injection/infusion
    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 INNUstekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    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 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 Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNVedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anti-TNF induced psoriasiform skin lesions in patients with inflammatory bowel diseases
    anti-TNF therapie veroorzaakte psoriasiforme huidletsels in patiënten met chronische onstekingsziekten van de darm
    E.1.1.1Medical condition in easily understood language
    Skin lesions induced by biological therapy used to treat patients with inflammatory bowel diseases
    huidletsels veroorzaakt door biologische medicatie die gebruikt wordt in de behandeling van patiënten met chronische onstekingsziekten van de darm
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this prospective, observational study is to indentify transcriptomic and proteomic signatures, which can predict good response to ustekinumab in anti-TNF treated patients with psoriasiform skin lesions
    Het primaire doel van de studie is om gen-en eiwitexpressie profielen te ontdekken die kunnen voorspellen of anti-TNF geïnduceerde psoriasiforme huidletsels goed reageren op een behandeling met ustekinumab
    E.2.2Secondary objectives of the trial
    The secondary objective will include elucidating the changes that occur in the psoriasiform skin lesions when the patient is switched from anti-TNF therapy to ustekinumab or vedolizumab. This is to better understand the mechanisms that contribute to the development of these psoriasiform skin lesions.
    Het secundaire eindpunt in deze studie is om de veranderingen in kaart te brengen die gebeuren op het niveau van de huid bij IBD patiënten met psoriasiforme huidletsels die een medicatie wissel ondergaan van anti-TNF therapie naar ustekinumab of vedolizumab. Dit is om de mechanismen die aan de ontwikkeling van de huidletsels liggen beter te kunnen begrijpen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All IBD patients aged 18 to 80-years-old who are currently being treated with anti-TNF therapy and who have developed psoriasiform skin lesions (including psoriasiform eczema, psoriasis guttata, psoriasis inversa and pustulosis) and which are refractory to at least 12 weeks of topical therapy. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
    Alle IBD patiënten tussen 18-80 jaar oud dit op heden behandeld worden met anti-TNF therapie en hieronder psoriasiforme huidletsels (inclusief psoriasisiform eczeem, psoriasis guttata, psoriasis inversa en pustulosa) ontwikkelden dewelke refractair zijn aan minstens 12 weken van topische behandeling. Voorafgaand aan hun inclusie dienen de deelnemers een schriftelijk toestemmingsformulier te ondertekenen.
    E.4Principal exclusion criteria
    - IBD patients not treated with anti-TNF therapy
    - IBD patients with paradoxical skin lesions due to anti-TNF who are not refractory to topical therapy
    - Patients who previously received anti-IL12/23 or anti-IL23 therapy or vedolizumab.
    - Pregnant IBD patients
    - IBD patiënten niet behandeld met anti-TNF therapie
    - IBD patiënten onder anti-TNF therapie die geen psoriasiforme huidletsels ontwikkelen
    - IBD patiënten met anti-TNF geïnduceerde psoriasiforme huidletsels die wel reageren op topische behandeling
    - zwangere IBD patiënten
    - IBD patiënten die ooit al werden behandeld met ustekinumab en/of vedolizumab
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is to identify gene and protein expression profiles that predict good response of anti-TNF induced psoriasiform skin lesions to ustekinumab
    het primaire eindpunt is om gen-en eiwitexpressie profielen te ontdekken die de goede respons van psoriasiforme huidletsels voorspellen op ustekinumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    within a year after termination of the study
    binnen het jaar na afsluiten van de studie
    E.5.2Secondary end point(s)
    The secondary end point is to identify mechanistic changes that occur in the skin when the study participants are switched from anti-TNF therapy to either ustekinumab or vedolizumab (control group).
    Het secundaire eindpunt is het bepalen van mechanistische veranderingen die optreden in de huid van de deelnemers wanneer hun medicatie wordt gewisseld naar ustekinumab of vedolizumab (controle groep)
    E.5.2.1Timepoint(s) of evaluation of this end point
    within the year after termination of the study
    binnen het jaar na het beëindigen van de studie
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For all patients the trial starts when they are switched to either to vedolizumab or ustekinumab due to the development of psoriasiform
    skin lesions and after signing a written informed consent, which shows that their participation is voluntary. For both groups the trial ends 16
    weeks after changing treatment.
    de studie begint op het moment dat de patiënt gewisseld wordt van anti-TNF therapie naar ofwel ustekinumab ofwel vedolizumab en
    eindigt na 16 weken.
    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 months0
    E.8.9.1In the Member State concerned 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    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)
    After termination of the trial, the patient can further be treated with ustekinumab or vedolizumab in daily clinical practice.
    Na het voltooien van de studie kunnen de deelnemers/patiënten verder behandeld worden met ustekinumab of vedolizumab volgens de richtlijnen van 'good clinical practice'.
    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 Decision2018-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 22:54:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA