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    Summary
    EudraCT Number:2018-001238-16
    Sponsor's Protocol Code Number:CNTO1959PSO3012
    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:2018-09-14
    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 number2018-001238-16
    A.3Full title of the trial
    A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    GUIDE
    A.4.1Sponsor's protocol code numberCNTO1959PSO3012
    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 NV
    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-Cilag International NV
    B.4.2CountryBelgium
    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 pointAnika Hunfeld
    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+492137955 3837
    B.5.5Fax number+492137955 6488
    B.5.6E-mailAHunfeld@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 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 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.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
    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 objective of the study is to demonstrate that Super-Responders maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (100 mg q16w).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate
    • whether subjects with short disease duration (≤2 years) show a more rapid and better guselkumab response compared to subjects with longer disease duration and whether subjects with shorter disease are more likely to maintain drug-free control of disease after guselkumab withdrawal. To be evaluated in Study Parts 1, 2 and 3.
    • whether SRe with short disease duration and PASI=0 at week 116 will show sustained remission (ie, PASI=0) over two additional years compared to subjects with longer disease duration. To be evaluated in Study Part 3.
    • whether SRe with short disease duration and PASI>0 to ≤5 at week 116 will show continued loss of response or stabilization of disease worsening over two additional years compared to subjects with longer disease duration. To be evaluated in Study Part 3.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies (part of the final protocol dated 05-Jul-2018):
    Four substudies are planned to further evaluate pharmacologic effects of guselkumab and evaluate various pharmacologic/clinical response relationships allowing assessment of inter-individual variability in clinical outcomes and possible identification of subject population groups that may respond differently to guselkumab. The substudies will also aim to further define the mechanism of action (MoA) of guselkumab at the molecular and cellular levels during and after treatment. Changes in gene expression as well as quantitative and qualitative changes in different types of immune cells will be evaluated in skin biopsies and blood.

    - Substudy 1 (Cellular MoA substudy)
    - Substudy 2 (Gene expression substudy)
    - Substudy 3 (Serum analysis)
    - Substudy 4 (Genetic analyses)


    Exploratory objectives
    The following objectives are to be explored in the mechanistic biomarker substudies:
    • characterization of the immune cellular and molecular composition at baseline (week 0) and changes in the lesional skin of subjects during treatment with guselkumab as determined by fluorescence activated cell sorting (FACS)-based analysis. To be explored in substudy 1
    • characterization of the immune cellular changes in the blood of subjects at baseline (week 0), during and after treatment with guselkumab as determined by FACS-based analysis. To be explored in substudy 1
    • characterization of molecular (gene expression) changes during treatment with guselkumab in the skin of subjects treated with guselkumab as determined by RNA sequencing (RNAseq) and quantitative polymerase chain reaction (qPCR). To be explored in substudy 2 and 3
    • characterization of the tissue immunopathological changes in the skin of subjects during and after treatment with guselkumab as determined by immunohistochemistry (IHC)/ immunofluorescence (IF)/ in situ hybridization (ISH). To be explored in substudy 2
    • characterization of the effects of guselkumab treatment on serum biomarkers as determined by immunoassays. To be explored in substudy 3
    • characterization of the association between changes in the various exploratory biomarker endpoints and 1) efficacy of guselkumab, 2) duration of psoriasis, 3) maintenance of response after stopping guselkumab treatment, and 4) ability to achieve a PASI 100 response at weeks 20 and 28 (super responder status). To be explored in all substudies
    E.3Principal inclusion criteria
    1. Male or female with at least 18 years of age.
    2. Has a disease duration of plaque psoriasis of either ≤2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration ≤2 years.
    3. Has moderate-to-severe plaque-psoriasis defined by a PASI score >10 or affected BSA >10% and additionally a DLQI score >10 at baseline (week 0).
    4. Is a candidate for systemic treatment for psoriasis.
    5. Before first administration of study drug, a woman must be:
    a. Not of childbearing potential
    b. Of childbearing potential and practicing a highly effective method of contraception

    For the complete overview of the inclusion criteria, please refer to
    section 4.1 of the protocol
    E.4Principal exclusion criteria
    1 clinical active psoriasis arthritis which needs systemic therapy beyond NSAIDs
    2 diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments 3 unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject
    4 Has a transplanted organ
    5 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

    For the complete overview of the exclusion criteria, please refer to
    section 4.2 of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the main study is the proportion of subjects in study groups 2a and 2b who achieve an absolute PASI score <3 at week 68.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 68
    E.5.2Secondary end point(s)
    Major secondary endpoints of this study are:
    • Time to improvement from baseline (week 0) in PASI (PASI 75/90/100 response and absolute PASI score = 0) for subjects with short (≤ 2 years) and longer (>2 years) disease duration per study group (1, 2a 2b, and 2c)
    • Proportion of subjects with short (≤2 years) and longer (>2 years) disease duration who achieve an absolute PASI score of 0, ≤1 and <3 at weeks 20, 28, 68, 116, 164 and 220 per study group (1, 2a, 2b, 2c, 3a and 3b)
    • Proportion of subjects who retain disease control (ie, absolute PASI score <3 at all visits) from week 68 through week 116, from week 68 through week 164, and from week 68 through week 220 for subjects with short (≤ 2 years) and longer (>2 years) disease duration per study group (3a and 3b).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12, 16, 20, 28, 36, 52, 68, 116, 164 and 220
    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 Yes
    E.6.10Pharmacogenetic No
    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 trial3
    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 concerned90
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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: 818
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state833
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 888
    F.4.2.2In the whole clinical trial 888
    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 Decision2019-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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