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    Summary
    EudraCT Number:2016-002135-15
    Sponsor's Protocol Code Number:CNTO1959PSO3008
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-01
    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 ConcernedGermany - PEI
    A.2EudraCT number2016-002135-15
    A.3Full title of the trial
    Multicenter, randomized, open-label, efficacy assessor-blinded, active comparator-controlled phase 3b study to compare the efficacy of guselkumab to fumaric acid esters (Fumaderm® initial/ Fumaderm®) for adult patients with moderate to severe plaque psoriasis who are candidates for and naive to systemic treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of guselkumab for patients with moderate to severe plaque psoriasis
    A.3.2Name or abbreviated title of the trial where available
    POLARIS
    A.4.1Sponsor's protocol code numberCNTO1959PSO3008
    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 SponsorJanssen-Cilag GmbH
    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 supportJanssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag GmbH
    B.5.2Functional name of contact pointSwantje Rielke
    B.5.3 Address:
    B.5.3.1Street AddressJohnson & Johnson Platz 1
    B.5.3.2Town/ cityNeuss
    B.5.3.3Post code41470
    B.5.3.4CountryGermany
    B.5.4Telephone number+492137955432
    B.5.5Fax number+492137955672
    B.5.6E-mailsrielke@its.jnj.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 nameGuselkumab
    D.3.2Product code CNTO1959
    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 INNGuselkumab
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB130392
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 Fumaderm initial / Fumaderm
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen GmbH
    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.3.1Product nameFumaderm initial / Fumaderm
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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
    Moderate to Severe Plaque Type Psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    The primary objectives of the study are
    • to compare the efficacy of guselkumab to fumaric acid esters (FAE) in systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis
    • to assess the safety and tolerability of guselkumab in systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are

    - in Study Parts I and II: to compare improvement of health-related quality of life (QOL) and other patient-reported outcomes (PRO) when systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis are treated with guselkumab compared to FAE.

    - in Study Part II: to compare sustainability of response to treatment when systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis are treated with guselkumab compared to FAE.

    - in Study Part III (guselkumab withdrawal): to investigate the maintenance of response in subjects withdrawn from study treatment, and to explore prediction parameters of disease modification.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female and ≥18 years of age
    2. Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
    3. Have a PASI >10 or BSA >10 at screening and at baseline
    4. Have a DLQI >10 at screening and at baseline
    5. Be a candidate for systemic treatment for psoriasis
    6. Topical psoriasis therapy is considered to be inadequate by the investigator due to
    - inadequate response to, intolerance to or contraindication against topical therapy in the subject’s medical history (documented or reported by the subject)
    - and/or disease severity at screening and at baseline
    7. Must be eligible for Fumaderm® treatment according to the SmPC
    8. Fumaderm® is considered, in the opinion of the investigator, to be an appropriate treatment option
    9. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
    10. A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0
    11. A woman must agree not to donate eggs for the purpose of assisted reproduction during the study and for a period of at least 12 weeks after receiving the last administration of study treatment
    12. During the study and for a minimum of 1 spermatogenesis cycle after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man
    • who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception during the study and for at least 12 weeks after receiving the last study treatment.
    • who is sexually active with a woman who is pregnant must use a condom, during the study and for at least 12 weeks after receiving the last administration of study treatment.
    • must agree not to donate sperm during the study and for at least 12 weeks after receiving the last administration of study treatment.
    13. Considered eligible according to the following tuberculosis screening criteria
    • Have no history of latent or active TB before screening. An exception is made for subjects who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first administration of study drug, or have documentation of having completed appropriate treatment for latent TB within 5 years before the first administration of study drug. It is the responsibility of the investigator to verify the adequacy of previous anti-tuberculosis treatment and provide appropriate documentation.
    • Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination
    • Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before first administration of study drug
    • Within 2 months before the first administration of study drug, have a negative QuantiFERON®-TB Gold Plus test result or have a newly identified positive QuantiFERON®-TB Gold Plus test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study drug.
    14. Have a chest radiograph taken within 3 months before the first administration of study drug and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB
    15. Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette-Guérin (BCG) vaccination
    16. Agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug
    17. Have screening laboratory test results within the following parameters, if one or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted:
    • Hematology panel within normal limits
    • Serum creatinine ≤1 × upper limit of normal
    • Aspartate aminotransferase, alanine aminotransferase, gamma-GT, total bilirubin and alkaline phosphatase levels must be ≤2 × ULN
    18. No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, eg, </=(+); one re-test (central urine analysis) is allowed.
    19. Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet (UV) light sources during study
    20. Be willing and able to adhere to the prohibitions and restrictions specified in this protocol
    21. Sign an informed consent form indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.
    E.4Principal exclusion criteria
    1. Has received prior systemic treatment of psoriasis including but not limited to
    - conventional systemic therapy (eg, methotrexate, cyclosporine, fumaric acid esters and acitretine)
    - apremilast and tofacitinib
    - drugs targeted for reducing TNF (including but not limited to infliximab, adalimumab or etanercept)
    - drugs targeted for reducing IL-12, IL-17, or IL-23 (including but not limited to ustekinumab, tildrakizumab [MK3222], secukinumab [AIN457], ixekizumab [LY2439821], or brodalumab [AMG827])
    - alpha-4 integrin antagonists (including but not limited to natalizumab)
    2. Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
    3. Has a history of malignancy within 5 years before screening (with the exception of a non-melanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before first study drug administration)
    4. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
    5. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug)
    6. Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
    7. Has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 2 months before screening
    8. Has or has had herpes zoster within the 2 months before screening
    9. Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
    10. Has a non-plaque form of psoriasis (eg, erythrodermic, guttate, or pustular)
    11. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
    12. Known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
    13. Contraindications to the use of Fumaderm® initial/ Fumaderm® per local prescribing information
    14. Has received phototherapy (including, but not limited to, PUVA, narrow-band UVB, balneophototherapy) within 4 weeks of the first administration of study drug
    15. Has used topical medications/ treatments that could affect psoriasis (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, pimecrolimus, tacrolimus, or topical traditional Taiwanese, Korean, or Chinese medicines) within 2 weeks of the first administration of study drug
    16. Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study drug; for BCG vaccine
    17. Has had a BCG vaccination within 12 months of screening
    18. Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mABs, or antibody fragments
    19. Has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
    20. Has a chest radiograph within 3 months before the first administration of study drug that shows an abnormality suggestive of a malignancy or current active infection, including TB
    21. Has ever had a non-tuberculous mycobacterial infection or opportunistic infection
    22. Has persistently indeterminate (indeterminate on repeat sampling) IGRA, eg, QuantiFERON®-TB Gold Plus test results
    23. Is infected with human immunodeficiency virus
    24. Tests positive for hepatitis B virus (HBV) infection or seropositive for antibodies to hepatitis C virus (HCV) at screening
    25. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or is currently enrolled in an investigational study
    26. Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug
    27. Plans to attempt to have a child while enrolled in this study or within 12 weeks after the last dose of study drug
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving at least a 90% improvement of their psoriasis according to the Psoriasis Area and Severity Index (PASI 90 response) at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    The major secondary endpoints are:
    • The proportion of subjects achieving at least a 75% improvement of their psoriasis according to the PASI (PASI 75 response) at Week 24
    • The proportion of subjects achieving a DLQI score of 0 or 1 at Week 24.

    Other secondary endpoints are:
    • The proportion of subjects achieving a 100% improvement of their psoriasis according to the PASI (PASI 100 response) at Week 24
    • The change from baseline in the signs and symptoms aggregate scores of the PSSD at Week 24
    • The change from baseline in the individual scale scores for itch, pain and scaling of PSSD components at Week 24
    • The proportion of subjects achieving an absolute PASI score ≤1 at Week 24
    • The proportion of subjects achieving an IGA score of cleared (0) at Week 24
    • The change from baseline of body surface area (BSA) psoriatic involvement at Week 24
    • The change from baseline in DLQI score at Week 24
    • The proportion of subjects achieving an ss-IGA score of absence of disease (0) at Week 24 in randomized subjects with scalp psoriasis and an ss-IGA score ≥2 at baseline
    • The change from baseline in the physical and mental component summary scores of SF-36 at Week 24
    • Maintenance of response. Proportion of subjects with a
    - PASI 75 response at Week 32 who maintain response at Week 56
    - PASI 90 response at Week 32 who maintain response at Week 56
    - DLQI score 0 or 1 at Week 32 who maintain response at Week 56
    - Proportion of subjects with a
    - PASI 75 response (compared to baseline) at Week 56
    - PASI 90 response (compared to baseline) at Week 56
    - PASI 100 response (compared to baseline) at Week 56
    - DLQI score 0 or 1 at Week 56
    - Proportion of subjects with a
    - PASI 75 response (compared to baseline) at Week 32
    - PASI 90 response (compared to baseline) at Week 32
    - PASI 100 response (compared to baseline) at Week 32
    - DLQI score 0 or 1 at Week 32
    - Maintenance of response after guselkumab withdrawal. Proportion of subjects of the guselkumab group (GUS-GUS and FAE-GUS) with a
    - PASI 90 response at Week 56 who maintain response at Week 100
    - Time to loss of response from Week 56 after guselkumab withdrawal at Week 100
    • Safety and tolerability data will be summarized using descriptive statistics.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24, Week 32 and Week 56
    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 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Untersucher-verblindet
    efficacy evaluator blinded
    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 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 concerned38
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state114
    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)
    There are no plans for additional treatment or care after the subject
    ends (or has ended) participation in the trial.
    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 Decision2016-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
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