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    The EU Clinical Trials Register currently displays   36818   clinical trials with a EudraCT protocol, of which   6079   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-003206-58
    Sponsor's Protocol Code Number:CNTO1959PSO3013
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-25
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-003206-58
    A.3Full title of the trial
    A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    G-PLUS
    A.4.1Sponsor's protocol code numberCNTO1959PSO3013
    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 International N.V.
    B.1.3.4CountryBelgium
    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 Pharmaceutica NV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Biologics B.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@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 Yes
    D.2.1.1.1Trade name TREMFYA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    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 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.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB179789
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal 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
    Palmoplantar non-Pustular 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
    To evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis
    E.2.2Secondary objectives of the trial
    1) To evaluate the efficacy of guselkumab in improving general plaque psoriasis in participants with palmoplantar psoriasis
    2) To evaluate the efficacy of guselkumab in improving clinician assessments and disease related patient-reported quality-of-life measures in participants with palmoplantar psoriasis.
    3) To evaluate the efficacy, patient-reported quality-of-life assessments and other scores in the placebo-crossover group at different time points.
    4) To evaluate the maintained efficacy of guselkumab for the treatment of palmoplantar psoriasis.
    5) To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis
    6) To evaluate safety of guselkumab in participants with palmoplantar psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant population-related inclusion criteria
    1. Male or female ≥18 years of age.
    2. Criterion changed per Amendment 1:
    2.1 Should have aall the following:
    - A confirmed diagnosis of moderate-to-severe palmoplantar-non pustular psoriasis with PASI score ≥3 and <10, with both palms and soles affected, withpalm and/or sole involvement and at least 1one plaque outside ofat a body site other than the palms or soles (any size), typically confirmingand soles for at least 6 months, to confirm a diagnosis of chronic psoriasis.
    - PASI score ≥3 and <10 at screening and at baseline.
    - ppIGA score ≥3 at screening and at baseline.
    3. Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included.
    4. Willing to participate in the study.
    Reproduction-related inclusion criteria
    5.Criterion changed per Amendment 1:
    5.1 Before the first administration of guselkumab, a woman must be either:
    • Not of childbearing potential
    • Of childbearing potential and practicing a highly effective method of contraception
    User-dependent methods of contraception: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogenonly hormone contraception associated with inhibition of ovulation: oral and injectable.
    • Agree to remain on a highly effective method throughout the study and for at least 12 weeks after the last dose of study intervention.
    6. Criterion changed per Amendment 1:
    6.1. A woman of childbearing potential must have a negative serum β- human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at screening and at Week 0.
    7. A woman must agree not to donate eggs for the purposes of assisted reproduction from the first administration of study intervention through at least 12 weeks after receiving the last administration of guselkumab.
    8. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control, during the study and for at least 12 weeks after receiving the last administration of study intervention. All men must also agree to not donate sperm during the study and for at least 12 weeks after receiving the last administration of study intervention.
    9. Is considered eligible according to the following TB screening criteria:
    a-c no updates compared to previous protocol
    d.Within 2 months before the first administration of study agent, has a negative QuantiFERON-TB test result, or has a newly identified positive QuantiFERON TB 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 agent. Within 2 months before the first administration of study agent, a negative tuberculin skin test (Appendix 2: Tuberculin Skin Testing), or a newly identified positive tuberculin skin test 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 agent, is additionally required if the QuantiFERON-TB test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities. A tuberculin skin test is recommended but not required for study centers in Ukraine if tuberculin is not available.
    Infectious disease-related inclusion criteria
    10. Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
    11. Agree not to receive a BCG vaccination during the study, and within 12 months after the last administration of study intervention.
    12. Criterion changed per Amendment 1:
    12.1 Have screening laboratory test results within the following parameters:
    Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels must be ≤12.50 times the upper limit of normal range for the central laboratory conducting the test.
    17 Criterion added per Amendment 1:
    Compliant with the completion requirements for the PROs used in the study.
    For a complete overview of the inclusion criteria, please refer page number 26 to 29 of the protocol.
    E.4Principal exclusion criteria
    Medical history-related exclusion criteria
    1. Criterion changed per Amendment 1:
    1.1 Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than or nontype 1 plaque-type psoriasis (eg, erythrodermic, guttate), or hyperkeratotic eczema. Any presence of pustules will not be allowed.
    2. Has psoriasis with >10% BSA (criterion deleted per Amendment 1)
    3. Has current drug-induced psoriasis.
    4. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study.
    5. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
    6. Criterion changed per Amendment 1:
    6.1 Is pregnant, nursing, or planning a pregnancy within while enrolled in this study, and for at least 12 weeks following after the last administration of study drug intervention. Concomitant or previous medical therapies-related exclusion criteria
    7.Criterion changed per Amendment 1:
    7.1 Has used topical anti-psoriatic medications/treatments that could affect efficacy evaluations (including, but not limited to, corticosteroids, vitamin D3 derivatives, tacrolimus, andsalicylic acid, urea, antibiotics) or any agents with anti-psoriatic effects) that could affect efficacy evaluations within 2 weeks of the planned first administration of study drug intervention.
    8. Has received prior treatment with biological agents for palmoplantarnon-pustular psoriasis.
    9. Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents.
    10. Criterion changed per Amendment 1:
    10.1 Has previously received MTX within 2 weeks, or any Disease-Modifying Anti Rheumatic Drugs (DMARDs) other than MTX within 4 weeks, including cyclosporin, fumarates and psoralen UVA (PUVA)within 4 weeks of the planned first administration of the study intervention.
    11.Criterion changed per Amendment 1:
    11.1 Has received phototherapy or any systemic medications/treatments that could affect efficacy evaluations (including, but not limited to, apremilast, systemic immunosuppressive drugs, biologic agents, cytotoxic drugs, JAK inhibitors, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatments, or traditional Taiwanese, Korean, or Chinese medicines) within 4 weeks of the planned first administration of study drug intervention.
    14. Has received, or is expected to receive, any live virus or bacteria vaccination within 3 months before the first administration of study drugintervention.
    17. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drugintervention).
    21. Has a chest radiograph within 3 months before the first administration of study drug intervention that shows an abnormality suggestive of a malignancy or current active infection, including TB
    26. Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug intervention administration).
    32. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocolspecified assessments (Criterion deleted per Amendment 1.)
    34. Is an employee of the sSponsor.
    For a complete overview of the exclusion criteria, refer page number 32 to 35 of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of ppPASI75 responders in the guselkumab group versus the placebo group at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    1. Change from baseline in BSA PASI and absolute PASI scores, and percentage change in PASI scores (PASI 75, 90 and 100) in the guselkumab group versus the placebo group at Week 16
    2. Change from baseline in PASI BSA and absolute PASI and BSA scores, and percentage change in PASI scores (PASI 75, 90 and 100) in the guselkumab group at Weeks 24 and 48
    3. Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group versus the placebo group at Week 16
    4. Change from baseline in f-PGA scores in the guselkumab group versus the placebo group at Week 16
    5. Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group at Weeks 24 and 48
    6. Change from baseline in f-PGA scores in the guselkumab group at Weeks 24 and 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,3,4,7: Week 16
    2,5,6,8,9,10,11: Week 24 and 48
    12: Throughout the study
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis and Tolerability
    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 No
    E.8.1.6Cross over Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    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 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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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)
    None
    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 Decision2019-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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