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    Summary
    EudraCT Number:2012-001377-88
    Sponsor's Protocol Code Number:MK-3222-011
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-001377-88
    A.3Full title of the trial
    A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab SCH 900222 / MK-3222, Followed by an Optional Long Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study to test the safety/tolerability and effectiveness of an investigational study medication (subcutaneous tildrakizumab (SCH 900222/MK-3222)) in improving the signs and symptoms of moderate-to-severe chronic plaque psoriasis, and to compare it to an approved medication for the treatment of psoriasis called etanercept.
    A.4.1Sponsor's protocol code numberMK-3222-011
    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 SponsorSun Pharma Global FZE
    B.1.3.4CountryUnited Arab Emirates
    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 supportSun Pharma Global FZE
    B.4.2CountryUnited Arab Emirates
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Advanced Research Company Ltd.
    B.5.2Functional name of contact pointShantanu Mehta
    B.5.3 Address:
    B.5.3.1Street Address17/B, Mahal Industrial Estate, Off Mahakali Caves Road
    B.5.3.2Town/ cityMumbai
    B.5.3.3Post code40093
    B.5.3.4CountryIndia
    B.5.4Telephone number+91 22 66455645
    B.5.6E-mailshantanu.mehta@sparcmail.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 nameTildrakizumab
    D.3.2Product code MK-3222 (SCH 900222)
    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 INNTildrakizumab
    D.3.9.1CAS number 1326244-10-3
    D.3.9.2Current sponsor codeMK-3222 (SCH 900222)
    D.3.9.3Other descriptive nameAnti-Human Interleukin-23 Monoclonal Antibody
    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 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 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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameENBREL
    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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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 Chronic Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Moderate-to-Severe Chronic Plaque Psoriasis
    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 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Efficacy Objective: To assess the efficacy of tildrakizumab (SCH 900222/MK-3222), hereafter referred
    to as tildrakizumab (MK-3222), compared to placebo in the treatment of moderate-to-severe chronic plaque
    psoriasis as measured by the proportion of subjects with at least 75% improvement in the Psoriasis Area and
    Severity Index from baseline (PASI 75 response) and the proportion of subjects with a Physician’s Global
    Assessment (PGA) score of “clear” or “minimal” with at least a 2 grade reduction from baseline at Week 12.

    Primary Safety/Tolerability Objective: To assess the safety/tolerability of tildrakizumab (MK-3222) in subjects
    with moderate-to-severe chronic plaque psoriasis at Week 12.

    Extension Study:
    To assess long-term safety and tolerability of tildrakizumab (MK-3222) in subjects with moderate-to-severe chronic plaque psoriasis for a minimum of 4 years.
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of tildrakizumab (MK-3222) compared to etanercept in the treatment of moderate to severe chronic plaque psoriasis as measured by the proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index from baseline (PASI 75 response) and the proportion of subjects with a Physician’s Global Assessment (PGA) score of “clear” or “minimal” with at least a 2 grade reduction from baseline at Week 12.

    2. To assess the efficacy of tildrakizumab (MK-3222) compared to etanercept in the treatment of moderate to severe chronic plaque psoriasis as measured by the proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index from baseline (PASI 75 response) and the proportion of subjects with a Physician's Global Assessment (PGA) score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 28.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects (≥18 years of age) with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area [BSA] involvement, PGA score ≥3, and PASI score ≥12 at Baseline [Visit 2])
    - Subjects must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator)
    - Subjects must be considered candidates for phototherapy or systemic therapy.
    E.4Principal exclusion criteria
    - Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
    - Subject with current, or history of, severe psoriatic arthritis and is well-controlled on current therapy.
    - Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial) or are lactating.
    - Subject who is expected to require topical therapy, phototherapy, or systemic therapy during the trial.
    - Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening.
    - Subject with any previous use of etanercept, tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors, including p40, p19, and IL-17 antagonists.
    - Subject is sensitive or allergic to latex.
    - Subject with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to first administration of study medication.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    - Proportion of subjects with PASI 75 response at Week 12
    - Proportion of subjects with a PGA score of “clear” or “minimal” with at least a 2 grade reduction from baseline at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    See section E.5.1 above.
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints
    - Proportion of subjects with PASI 75 response at Week 28
    - Proportion of subjects with a PGA score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 28.
    - Proportion of subjects with PASI 90 response at Week 12
    - Proportion of subjects with PASI 100 response at Week 12

    Other Secondary Efficacy Endpoints Part 1 (Weeks 0-12)
    - Change in DLQI from baseline at Week 12
    - Proportion of subjects with a DLQI score of 0 or 1 at Week 12
    - Change and percent change in PASI score at Week 12 Parts 2 to 3 (Weeks 12-52)
    - Proportion of subjects with PASI 75 response at Weeks 40 and 52
    - Proportion of subjects with PASI 90 response at Weeks 28, 40, and 52
    - Proportion of subjects with PASI 100 response at Weeks 28, 40, and 52
    - Proportion of subjects with PGA score "clear" or "minimal" with at least a 2 grade reduction from baseline at Weeks 40 and 52
    - Proportion of subjects with a DLQI score of 0 or 1 at Weeks 28, 40, and 52
    - Change in DLQI from baseline at Weeks 28, 40, and 52
    - Proportion of subjects with PASI 75 response and proportion of subjects with PGA score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 52, among partial responders who increased their dose of tildrakizumab (MK-3222) (from 100 mg to 200 mg) at Week 28
    - Proportion of subjects with PASI 75 response and proportion of subjects with PGA score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 52, among responders who decreased their dose of tildrakizumab (MK-3222) (from 200 mg to 100 mg) at Week 28
    - Proportion of subjects with PASI 75 response and proportion of subjects with PGA score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 52 among etanercept non-responders (subjects who achieve PASI response <75% at Week 28) who crossed over to tildrakizumab (MK-3222)
    - Change and percent change from baseline in PASI score over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2 above.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Anti-drug antibody
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1050
    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)
    Subjects who complete Part 3 of the trial may be eligible to participate in a long-term extension study. Subjects who elect to participate in the long-term extension study will participate for an additional 192 weeks (minimum of 4 years). The 20-week follow up period applies to all subjects who complete the study. Subjects may continue to receive treatment beyond 192 weeks until the product is commercially available in the subject´s local market or until December 2020 whichever comes first.
    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 Decision2013-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-12
    P. End of Trial
    P.End of Trial StatusOngoing
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